Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- EMFKnife, Surgical1Product Code
- EPTMicroscope, Surgical1Product Code
- EPWSupport, Head, Surgical, Ent1Product Code
- OEJTransurethral Electrosurgical Unit, Benign Prostatic Hyperplasia2Product Code
- FAZSystem, Cryosurgical, Liquid Nitrogen, For Urology2Product Code
- OEKWater-Induced Thermotherapy System, Benign Prostatic Hyperplasia2Product Code
- GAGStapler, Surgical2Product Code
- DWGElectrosurgical Device2Product Code
- DWHBlade, Saw, Surgical, Cardiovascular1Product Code
- DWISaw, Electrically Powered1Product Code
- DWONeedle, Biopsy, Cardiovascular1Product Code
- QQSStapler, Skin1Product Code
- BTAPump, Portable, Aspiration (Manual Or Powered)2Product Code
- BWAUnit, Electrosurgical And Coagulation, With Accessories2Product Code
- BWNTable And Attachments, Operating-Room1Product Code
- BWPShoe And Shoe Cover, Conductive1Product Code
- FGYCannula, Injection1Product Code
- FHMApparatus, Suturing, Stomach And Intestinal1Product Code
- FHRNeedle, Gastro-Urology1Product Code
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature2Product Code
- FNWPad, Kelly2Product Code
- FQOTable, Operating-Room, Ac-Powered1Product Code
- FQPLamp, Operating-Room2Product Code
- FSETable, Operating-Room, Manual1Product Code
- FSHTray, Surgical, Needle1Product Code
- FSMTray, Surgical, Instrument1Product Code
- FSOMicroscope, Surgical, General & Plastic Surgery1Product Code
- FSPLoupe, Diagnostic/Surgical1Product Code
- FSQLight, Surgical, Instrument2Product Code
- FSSLight, Surgical, Floor Standing2Product Code
- FSTLight, Surgical, Fiberoptic2Product Code
- FSWLight, Surgical, Endoscopic2Product Code
- FSXLight, Surgical, Connector2Product Code
- FSYLight, Surgical, Ceiling Mounted2Product Code
- FSZLight, Surgical, Carrier2Product Code
- FTALight, Surgical, Accessories2Product Code
- FTCLight, Ultraviolet, Dermatological2Product Code
- FTDLamp, Surgical2Product Code
- FTFIlluminator, Non-Remote2Product Code
- FTGIlluminator, Remote2Product Code
- FTHCamera, Still, Microsurgical1Product Code
- FTSCamera, Cine, Endoscopic, With Audio1Product Code
- FTTCamera, Still, Surgical1Product Code
- FTXMirror, General & Plastic Surgery1Product Code
- FTYTape, Measuring, Rulers And Calipers1Product Code
- FWBCamera, Television, Surgical, Without Audio1Product Code
- FWCCamera, Television, Surgical, With Audio1Product Code
- FWDCamera, Television, Microsurgical, Without Audio1Product Code
- FWECamera, Television, Microsurgical, With Audio1Product Code
- FWFCamera, Television, Endoscopic, Without Audio1Product Code
- FWGCamera, Television, Endoscopic, With Audio1Product Code
- FWHCamera, Cine, Surgical, Without Audio1Product Code
- FWICamera, Cine, Surgical, With Audio1Product Code
- FWJCamera, Cine, Microsurgical, Without Audio1Product Code
- FWKCamera, Cine, Microsurgical, With Audio1Product Code
- FWLCamera, Cine, Endoscopic, Without Audio1Product Code
- FWWTable, Operating-Room, Pneumatic1Product Code
- FWXTable, Operating-Room, Mechanical1Product Code
- FWYTable, Operating-Room, Non-Electrical1Product Code
- FWZOperating Room Accessories Table Tray1Product Code
- FXMCamera, Still, Endoscopic1Product Code
- FXNTape, Camera, Surgical1Product Code
- FXQLens, Camera, Surgical1Product Code
- FXRHolder, Camera, Surgical1Product Code
- FXSFrame, Camera, Surgical1Product Code
- FXTFilm, Camera, Surgical1Product Code
- FXWShoes, Operating-Room1Product Code
- FYEDress, Surgical1Product Code
- FYFCap, Surgical1Product Code
- FZKChair, Surgical, Non-Electrical1Product Code
- FZMStool, Operating-Room1Product Code
- FZOChisel, Surgical, Manual1Product Code
- FZPClip, Implantable2Product Code
- FZQClip, Removable (Skin)1Product Code
- FZRContractor, Surgical1Product Code
- FZSCurette, Surgical, General Use1Product Code
- FZTCutter, Surgical1Product Code
- FZWExpander, Surgical, Skin Graft1Product Code
- FZXGuide, Surgical, Instrument1Product Code
- FZYHammer, Surgical1Product Code
- FZZMarker, Skin1Product Code
- GAANeedle, Aspiration And Injection, Disposable1Product Code
- GABNeedle, Suturing, Disposable1Product Code
- GACRasp, Surgical, General & Plastic Surgery1Product Code
- GADRetractor1Product Code
- GAESnare, Surgical1Product Code
- GAFSpatula, Surgical, General & Plastic Surgery1Product Code
- GAHStylet, Surgical, General & Plastic Surgery1Product Code
- GAIStripper, Vein, Reusable1Product Code
- GAJStripper, Vein, Disposable1Product Code
- GAKSuture, Absorbable2Product Code
- GALSuture, Absorbable, Natural2Product Code
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid2Product Code
- GANSuture, Absorbable, Synthetic2Product Code
- GAOSuture, Nonabsorbable2Product Code
- GAPSuture, Nonabsorbable, Silk2Product Code
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile2Product Code
- GARSuture, Nonabsorbable, Synthetic, Polyamide2Product Code
- GASSuture, Nonabsorbable, Synthetic, Polyester2Product Code
- GATSuture, Nonabsorbable, Synthetic, Polyethylene2Product Code
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene2Product Code
- GBACatheter, Balloon Type1Product Code
- GBBChair, Surgical, Ac-Powered1Product Code
- GBCLamp, Surgical, Incandescent2Product Code
- GBNCatheter, Pediatric, General & Plastic Surgery1Product Code
- GBOCatheter, Nephrostomy, General & Plastic Surgery1Product Code
- GBPCatheter, Multiple Lumen1Product Code
- GBQCatheter, Continuous Irrigation1Product Code
- GBSCatheter, Ventricular, General & Plastic Surgery1Product Code
- GBWCatheter, Peritoneal1Product Code
- GBXCatheter, Irrigation1Product Code
- GBYCatheter, Eustachian, General & Plastic Surgery1Product Code
- GBZCatheter, Cholangiography1Product Code
- GCBNeedle, Catheter1Product Code
- GCCDilator, Catheter1Product Code
- GCDConnector, Catheter1Product Code
- GCEAdaptor, Catheter1Product Code
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered1Product Code
- GCZRetainer, Surgical1Product Code
- GDCTable, Operating-Room, Electrical1Product Code
- GDFGuide, Needle, Surgical1Product Code
- GDGHook, Surgical, General & Plastic Surgery1Product Code
- GDHGouge, Surgical, General & Plastic Surgery1Product Code
- GDIDissector, Surgical, General & Plastic Surgery1Product Code
- GDJClamp, Surgical, General & Plastic Surgery1Product Code
- GDLNeedle, Suturing, Reusable1Product Code
- GDMNeedle, Aspiration And Injection, Reusable1Product Code
- GDNKnife, Amputation1Product Code
- GDOApplier, Surgical, Clip1Product Code
- GDRSaw, Manual And Accessories1Product Code
- GDTStaple, Removable (Skin)1Product Code
- GDWStaple, Implantable2Product Code
- GDXScalpel, One-Piece1Product Code
- GDYGauze/Sponge, Internal, X-Ray Detectable1Product Code
- GDZHandle, Scalpel1Product Code
- GEACannula, Surgical, General & Plastic Surgery1Product Code
- GECBrush, Scrub, Operating-Room1Product Code
- GEDBrush, Dermabrasion, Manual1Product Code
- GEEBrush, Biopsy, General & Plastic Surgery1Product Code
- GEFApplier, Staple, Surgical,1Product Code
- GEGElevator, Surgical, General & Plastic Surgery1Product Code
- GEHUnit, Cryosurgical, Accessories2Product Code
- K242803Compound W Skin Tag Remover2Cleared 510(K)
- K242625Freeze Point & Private Label Versions2Cleared 510(K)
- K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)2Cleared 510(K)
- K240776Celsio Flexible Cryocatheter System2Cleared 510(K)
- K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)2Cleared 510(K)
- K240892XSense Cryoablation System with Cryoprobes2Cleared 510(K)
- K240106Histofreezer V2Cleared 510(K)
- K234002ICEfx Cryoablation System (FPRCH8000-02)2Cleared 510(K)
- K233347Verruca-Freeze® H2Cleared 510(K)
- K231661CryoThin™ Surgical System and Accessories2Cleared 510(K)
- K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)2Cleared 510(K)
- K230551Visual-ICE Cryoablation System2Cleared 510(K)
- K230599TargetCool™2Cleared 510(K)
- K221897Hydrozid Precise2Cleared 510(K)
- K222356Claritag Advanced2Cleared 510(K)
- K230271ISOLIS Cryoprobe2Cleared 510(K)
- K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 20001842Cleared 510(K)
- K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 20001842Cleared 510(K)
- K221234TargetCool2Cleared 510(K)
- K211099Freeze’n Clear Skin Clinic Warts & Tags2Cleared 510(K)
- K220674TargetCool2Cleared 510(K)
- K211149Urethral Warming Catheter Kit2Cleared 510(K)
- K212814C2 CryoBalloon Ablation System2Cleared 510(K)
- K210310CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit2Cleared 510(K)
- K201740Hydrozid2Cleared 510(K)
- K203481CryoVIVE2Cleared 510(K)
- K210529Dr. Yglo Wart Remover2Cleared 510(K)
- K201366Forwarts2Cleared 510(K)
- K201183Vortex Radial Spray Catheter2Cleared 510(K)
- K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge2Cleared 510(K)
- K203032IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle2Cleared 510(K)
- K201260Dermal Cooling System2Cleared 510(K)
- K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice2Cleared 510(K)
- K193665Frozen N2Cleared 510(K)
- K193619Cry-Ac®, Cry-Ac-3®, Cry-Baby2Cleared 510(K)
- K190651ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter2Cleared 510(K)
- K183213IceSense 3, ProSense, MultiSense2Cleared 510(K)
- K190747Claritag2Cleared 510(K)
- K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge2Cleared 510(K)
- K190407CryoLab2Cleared 510(K)
- K183601CryoTouch2Cleared 510(K)
- K190356ClariFix2Cleared 510(K)
- K182392Frozen C2Cleared 510(K)
- K181741IceSphere 1.5 CX Cryoablation Needle2Cleared 510(K)
- K181153ICEfx Cryoablation System2Cleared 510(K)
- K180211Freezpoint2Cleared 510(K)
- K180137AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)2Cleared 510(K)
- K163684C2 CryoBalloon Ablation System2Cleared 510(K)
- K172769CryOmega Flexx2Cleared 510(K)
- K173037Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel2Cleared 510(K)
- K172373Compound W Nitro-Freeze2Cleared 510(K)
- K170810CRYOFOS2Cleared 510(K)
- K172049CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED2Cleared 510(K)
- K171626truFreeze System2Cleared 510(K)
- K172041truFreeze System2Cleared 510(K)
- K171522truFreeze Rapid AV Spray Kit2Cleared 510(K)
- K171398Dermal Cooling System2Cleared 510(K)
- K163244truFreeze System2Cleared 510(K)
- K162608ClariFix Device2Cleared 510(K)
- K161202C2 Cryoballoon Ablation System2Cleared 510(K)
- K162695truFreeze System2Cleared 510(K)
- K162599IcePearl 2.1 CX L, IceForce 2.1 CX L2Cleared 510(K)
- K161480R2 Dermal Cooling System2Cleared 510(K)
- K161294Compound W Wart Removal System Dual Power2Cleared 510(K)
- K161615Accurett2Cleared 510(K)
- K161557truFreeze System2Cleared 510(K)
- K161337CryoDose H or Similar2Cleared 510(K)
- K161296Cool Renewal2Cleared 510(K)
- K160669ClariFix Device2Cleared 510(K)
- K160994C2 CryoBalloon Focal Pear Catheter2Cleared 510(K)
- K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System2Cleared 510(K)
- K160273truFreeze System2Cleared 510(K)
- K152337cryoFORM cryoICE cryoablation probe2Cleared 510(K)
- K153489Cryocare CS Surgical System2Cleared 510(K)
- K153541Coldplay CryoBalloon® Ablation System2Cleared 510(K)
- K152203UTERMOHLEN CRYO PROFESSIONAL2Cleared 510(K)
- K152668truFreeze System2Cleared 510(K)
- K151968Cryocare CS-3 Surgical System version 52Cleared 510(K)
- K152133IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System2Cleared 510(K)
- K151309Wartie Advanced Wart Remover or other proprietary name2Cleared 510(K)
- K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System2Cleared 510(K)
- K141110CRYOCARE CS SURGICAL SYSTEM2Cleared 510(K)
- K150920truFreeze System2Cleared 510(K)
- K151041ERBECRYO 2 Cryosurgical Unit with accessories2Cleared 510(K)
- K143564Visual-ICE Cryoablation System, Software Revision 1.3.12Cleared 510(K)
- K143625truFreeze System2Cleared 510(K)
- K142441cryoICE croablation probe2Cleared 510(K)
- K141485ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE2Cleared 510(K)
- K133258TRUFREEZE SYSTEM2Cleared 510(K)
- K140314WARTIE WART REMOVER2Cleared 510(K)
- K140584ICEROD CX CRYOABLATION NEEDLE2Cleared 510(K)
- K140058ATRICURE CRYO MODULE SYSTEM2Cleared 510(K)
- K131523CRYOBALLOON FOCAL ABLATION SYSTEM2Cleared 510(K)
- K130995NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY2Cleared 510(K)
- K130599WART FREEZE2Cleared 510(K)
- K123865VISUAL-ICE CRYOABLATION SYSTEM2Cleared 510(K)
- K121251ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK2Cleared 510(K)
- K121507ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)2Cleared 510(K)
- K113860VISUAL-ICE CRYOABLATION SYSTEM2Cleared 510(K)
- K113021TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT2Cleared 510(K)
- K111859ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK2Cleared 510(K)
- K110754CRYOPEN CRYOSURGICAL SYSTEM, K1022142Cleared 510(K)
- K112072ATRICURE CRYO MODULE SYSTEM2Cleared 510(K)
- K101049WART FREEZE2Cleared 510(K)
- K110946ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE2Cleared 510(K)
- K111042ATRICURE CRYO MODULE2Cleared 510(K)
- K103310CRYONIZE TM2Cleared 510(K)
- K102360ICESENCE 32Cleared 510(K)
- K102006CRYOMEGA2Cleared 510(K)
- K101825CRYOBALLOON ABLATION SYSTEM2Cleared 510(K)
- K101333CRYOCARE CS SURGICAL SYSTEM2Cleared 510(K)
- K091721CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-232Cleared 510(K)
- K090978UC-CARE WARMING SYSTEM2Cleared 510(K)
- K083493MYOSCIENCE CRYO-TOUCH2Cleared 510(K)
- K082074ATRICURE CRYO1 CRYO-ABLATION PROBE2Cleared 510(K)
- K073533SANARUS V2 TREATMENT SYSTEM2Cleared 510(K)
- K072883ICE-SENSE2Cleared 510(K)
- K072651CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM2Cleared 510(K)
- K072453CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T2Cleared 510(K)
- K070893CRYOSPRAY ABLATION SYSTEM, MODEL CU 84070205002Cleared 510(K)
- K070482ISIS2Cleared 510(K)
- K062896V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD06002Cleared 510(K)
- K062175CRYOCARE CN2 SYSTEM2Cleared 510(K)
- K061510SANARUS VISICA TREATMENT SYSTEM2Cleared 510(K)
- K060859COMPOUND W FREEZE OFF WART REMOVAL SYSTEM2Cleared 510(K)
- K060928CRYOSHAPE2Cleared 510(K)
- K060390SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA2Cleared 510(K)
- K060555SPRAYGENIX CRYO ABLATION SYSTEM2Cleared 510(K)
- K060279CRYOCARE CS SURGICAL SYSTEM2Cleared 510(K)
- K060144SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS2Cleared 510(K)
- K052259DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 404062Cleared 510(K)
- K052530SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA2Cleared 510(K)
- K052861MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS20002Cleared 510(K)
- K051509ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES2Cleared 510(K)
- K051052SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)2Cleared 510(K)
- K050347MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM2Cleared 510(K)
- K042667SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD)2Cleared 510(K)
- K041783POLAR WAND2Cleared 510(K)
- K040809CRYMED CRYO-ABLATOR2Cleared 510(K)
- K032271WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022)2Cleared 510(K)
- K031697DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 402262Cleared 510(K)
- K032333CRYOCARE CS SURGICAL SYSTEM2Cleared 510(K)
- K030838WARTNER PRO2Cleared 510(K)
- K031117SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM2Cleared 510(K)
- K030303FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE2Cleared 510(K)
- K024009CRYOPROBE2Cleared 510(K)
- K023487HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME2Cleared 510(K)
- K023757CRYOCARE SURGICAL SYSTEM, MODEL CRYO 202Cleared 510(K)
- K022314SANARUS VISICA TREATMENT SYSTEM2Cleared 510(K)
- K021387POLAR WAND2Cleared 510(K)
- K021261SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T32Cleared 510(K)
- K021211MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM2Cleared 510(K)
- K012214CRYOPEN AND ACCESSORIES2Cleared 510(K)
- K020605SANARUS VISICA TREATMENT SYSTEM2Cleared 510(K)
- K011708MODIFICATION TO WARTNER WART REMOVAL SYSTEM2Cleared 510(K)
- K011950SEEDNET, MODEL FP6T5, FP5T5, FP5T32Cleared 510(K)
- K011074CRYOCARE SURGICAL SYSTEM2Cleared 510(K)
- K012497CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T12Cleared 510(K)
- K003811CRYOCARE SURGICAL SYSTEM2Cleared 510(K)
- K011073CRYOPLAN SYSTEM2Cleared 510(K)
- K010991SEEDNET, MODELS FP6T5, FP5T5, FP5T32Cleared 510(K)
- K002714WARTNER WART REMOVAL SYSTEM2Cleared 510(K)
- K002615SURGICAL SYSTEM WITH CRYOGUIDE2Cleared 510(K)
- K003065SEEDNET, MODEL EP6T5, EP5E52Cleared 510(K)
- K993965CRYO-HIT2Cleared 510(K)
- K991792CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE2Cleared 510(K)
- K991517CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T52Cleared 510(K)
- K991272CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E2Cleared 510(K)
- K991122CRYO-MONO CRYOGRNIC SYSTEM2Cleared 510(K)
- K990877HISTOFREEZER DEVICE2Cleared 510(K)
- K982506VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM2Cleared 510(K)
- K982280CRYOPRO MAXI AND CRYOPRO MINI2Cleared 510(K)
- K982358HISTOFREEZER DEVICE2Cleared 510(K)
- K982055ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 8802Cleared 510(K)
- K980668CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 7902Cleared 510(K)
- K980670CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 7222Cleared 510(K)
- K980739HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS2Cleared 510(K)
- K980110ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM2Cleared 510(K)
- K973686ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM2Cleared 510(K)
- K971392HISTOFREEZER VERRUCA PLANA2Cleared 510(K)
- K972662CRYOGEN CRYOSURGICAL SYSTEM2Cleared 510(K)
- K970995CMS CRYOLITE2Cleared 510(K)
- K970992PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS2Cleared 510(K)
- K971216FRIGIDERM FRIGISPRAY2Cleared 510(K)
- K964971CRYOGEN CRYOSURGICAL SYSTEM2Cleared 510(K)
- K964336CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 6802Cleared 510(K)
- K964047CRYOSIL SILICONE GEL SHEETING2Cleared 510(K)
- K963970ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM2Cleared 510(K)
- K963826ENDOCARE CRYCARE CRYOSURGICAL SYSTEM2Cleared 510(K)
- K961219PERCUTANEOUS INTRODUCER SYSTEM2Cleared 510(K)
- K955011CANDELA HCS 2000 URETHERAL WARMER CATHETER2Cleared 510(K)
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- K914591L.C.S. 2000 SYSTEM2Cleared 510(K)
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- K910491WALLACH COLD SOAKER2Cleared 510(K)
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- K892237THE FERN CRYOPROBE2Cleared 510(K)
- K891282MIC-100 WITH CRYOPROBES2Cleared 510(K)
- K882568130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY2Cleared 510(K)
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- K882962SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)2Cleared 510(K)
- K882963SPEMBLY MEDICAL 142 CRYO UNIT2Cleared 510(K)
- K881349VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM2Cleared 510(K)
- K872796ADDITIONS TO WSL NITROSPRAY CRYOSURGICAL UNITS2Cleared 510(K)
- K871314CRYOSURGICAL PROBE2Cleared 510(K)
- K854767LM 10002Cleared 510(K)
- K844246NETHERY EXTREMITY FREEZING UNIT2Cleared 510(K)
- K842959MC-4000 CONSOLE & PROBES2Cleared 510(K)
- K842704MT-700 MT-750 FT-3502Cleared 510(K)
- K840536CRYO SURG 59002Cleared 510(K)
- K832385CRYOPROBES MC-1400-CRYOSURG-CONSOLE2Cleared 510(K)
- K832334CRYOMEDICS 5000 CRYOSURGICAL CONSOLE2Cleared 510(K)
- K832140CRYOMEDICS 5000 CRYOPROBES2Cleared 510(K)
- K813024WA10002Cleared 510(K)
- K811390CCS100 CRYOSURGICAL SYSTEM2Cleared 510(K)
- K810409MODEL C2100-SERIES OPHTHALMIC CRYOPROBE2Cleared 510(K)
- K803311LL100 CRYOSURGICAL SYSTEM2Cleared 510(K)
- K801921GCS-792Cleared 510(K)
- K800335KRYMED LIQUID NITROGEN CRYOJET2Cleared 510(K)
- K781956CRYOSURGICAL DEVICE 20002Cleared 510(K)
- K772232LIQUID NITROGEN SPRAY UNIT2Cleared 510(K)
- K771320CRYOSURGICAL EQUIPMENT2Cleared 510(K)
- K770058PROBE, VACUUM INSULATED, SERIES 302Cleared 510(K)
- K760953DEEP FREEZE SYSTEM (DFS-30)2Cleared 510(K)
- K760742CS-76 AND/OR CRYOCARE I2Cleared 510(K)
- K760686CRYOLYZER ALPHA (CRYOSURG.EQUIP.)2Cleared 510(K)
- K760353CRYOLYZER ALPHA2Cleared 510(K)
- GEIElectrosurgical, Cutting & Coagulation & Accessories2Product Code
- GEJCarrier, Ligature1Product Code
- GENForceps, General & Plastic Surgery1Product Code
- GEOFile, Surgical, General & Plastic Surgery1Product Code
- GESBlade, Scalpel1Product Code
- GETMotor, Surgical Instrument, Pneumatic Powered1Product Code
- GEXPowered Laser Surgical Instrument2Product Code
- GEYMotor, Surgical Instrument, Ac-Powered1Product Code
- GFABlade, Saw, General & Plastic Surgery, Surgical1Product Code
- GFBHead, Surgical, Hammer1Product Code
- GFCDriver, Surgical, Pin1Product Code
- GFDDermatome1Product Code
- GFEBrush, Dermabrasion, Powered1Product Code
- GFFBur, Surgical, General & Plastic Surgery1Product Code
- GFGBit, Surgical1Product Code
- GFIOsteotome, Manual1Product Code
- GFJMallet, Surgical, General & Plastic Surgery1Product Code
- HABSaw, Powered, And Accessories1Product Code
- HAMApparatus, Electrosurgical2Product Code
- HBIIlluminator, Fiberoptic, Surgical Field2Product Code
- HBTApplier, Hemostatic Clip1Product Code
- HCFInstrument, Ligature Passing And Knot Tying1Product Code
- HJELamp, Fluorescein, Ac-Powered2Product Code
- HMPPad, Eye1Product Code
- HRBMicroscope, Operating, Non-Electric, Ophthalmic1Product Code
- HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic1Product Code
- HRQHemostat1Product Code
- HSOSaw1Product Code
- HTCPliers, Surgical1Product Code
- HTDForceps1Product Code
- HTEElevator1Product Code
- HTFCurette1Product Code
- HTRRasp1Product Code
- HTZInstrument, Cutting, Orthopedic1Product Code
- HWMOsteotome1Product Code
- HXDClamp1Product Code
- HXLMallet1Product Code
- HXRSpatula, Orthopedic1Product Code
- HXTTape, Orthopedic1Product Code
- HYAForceps, Wire Holding1Product Code
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered2Product Code
- JCYCatheter, Infusion1Product Code
- JEATable, Surgical With Orthopedic Accessories, Ac-Powered1Product Code
- JEBTable, Surgical With Orthopedic Accessories, Manual1Product Code
- JOSElectrode, Electrosurgical2Product Code
- JOTElectrode, Gel, Electrosurgical2Product Code
- JYCCannula, Ear1Product Code
- JYDChisel, Mastoid1Product Code
- KAMCannula, Sinus1Product Code
- KANChisel, Nasal1Product Code
- KCECannulae, Bronchial1Product Code
- KDCInstrument, Surgical, Disposable1Product Code
- KDDKit, Surgical Instrument, Disposable1Product Code
- KDGChisel (Osteotome)1Product Code
- KFKSaw, Pneumatically Powered1Product Code
- KGLCabinet, Phototherapy (Puva)2Product Code
- KGSRetention Device, Suture1Product Code
- KGWRing (Wound Protector), Drape Retention, Internal2Product Code
- KGYBag, Intestine1Product Code
- KGZAccessories, Catheter1Product Code
- KIKHook, Bone1Product Code
- KOXSolvent, Adhesive Tape1Product Code
- KOYDegreaser, Skin, Surgical1Product Code
- KOZBeads, Hydrophilic, For Wound Exudate Absorption1Product Code
- KQMCamera, Surgical And Accessories1Product Code
- LEJBooth, Sun Tan2Product Code
- LMFAgent, Absorbable Hemostatic, Collagen Based3Product Code
- LMGAgent, Absorbable Hemostatic, Non-Collagen Based3Product Code
- LROGeneral Surgery Tray2Product Code
- LRPTray, Surgical1Product Code
- LRWScissors, General, Surgical1Product Code
- LRYPunch, Surgical1Product Code
- LRZScrewdriver, Surgical1Product Code
- LSAVise, Bench, Surgical1Product Code
- LWGSurgical Table Cushion1Product Code
- LWKRazor, Surgical1Product Code
- LXKScrapper, Skin Specimen1Product Code
- LXZGuard, Instrument1Product Code
- LYVLabel Or Tag, Sterile1Product Code
- LZMGuard, Skin Graft1Product Code
- MCHClip, Hemostatic2Product Code
- MCZSuture Removal Kit1Product Code
- MDAElastomer, Silicone, For Scar Management1Product Code
- MDMInstrument, Manual, Surgical, General Use1Product Code
- MGOClosure, Wound, Adhesive1Product Code
- MIJNeedle, Tumor Localization1Product Code
- MJGDevice, Percutaneous, Biopsy1Product Code
- MKYSystem, Skin Closure1Product Code
- MOQBattery, Replacement, Rechargeable1Product Code
- MPNTissue Adhesive For The Topical Approximation Of Skin2Product Code
- MULGenerator, Electrosurgical, Coagulation, Cancer2Product Code
- MUUSystem, Suction, Lipoplasty2Product Code
- MVRDevice, Anastomotic, Microvascular2Product Code
- MWYSystem, Microwave, Hair Removal2Product Code
- MXGLamp, Uvc, (For Treating Skin And Wounds)2Product Code
- MXWSuture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)2Product Code
- NABGauze / Sponge,Nonresorbable For External Use1Product Code
- NACDressing, Wound, Hydrophilic1Product Code
- NADDressing, Wound, Occlusive1Product Code
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic1Product Code
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene2Product Code
- NCAClip, Implantable, For Coronary Artery Bypass Graft (Cabg)2Product Code
- NEHAnchor, Fascial2Product Code
- NEUMarker, Radiographic, Implantable2Product Code
- NEWSuture, Surgical, Absorbable, Polydioxanone2Product Code
- NEYSystem, Ablation, Microwave And Accessories2Product Code
- NJCClip, Vas Deferens2Product Code
- NJUSuture, Nonabsorbable, Nitinol2Product Code
- NJZExtractor, Vein1Product Code
- NLKNeedle, Biopsy, Cardiovascular, Reprocessed1Product Code
- NLLStaple, Implantable, Reprocessed2Product Code
- NMJClip, Implantable, Reprocessed2Product Code
- NMTNeedle, Catheter, Reprocessed1Product Code
- NMUNeedle, Gastro-Urology, Reprocessed1Product Code
- NNABiopsy Device, Percutaneous, Reprocessed1Product Code
- NNCNeedle, Aspiration And Needle, Reprocessed1Product Code
- NRBWound Cleaner, Ultrasound2Product Code
- NRJUltrasound, Skin Permeation2Product Code
- NTBSystem, Ablation, Ultrasound And Accessories2Product Code
- NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed2Product Code
- NUVMassager, Vacuum, Light Induced Heating2Product Code
- NVHSuture, Knot, Mechanical2Product Code
- NVJApplicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women2Product Code
- NWFDrill, Battery Powered, Subungual Hematoma1Product Code
- NWJSuture, Recombinant Technology2Product Code
- NXFGas, Laser Generating1Product Code
- NYSWound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)2Product Code
- OABLow Energy Direct Current Thermal Ablation System2Product Code
- ODRElectrosurgical Patient Return Electrode2Product Code
- OEIDrainage Catheter With Antibiotic2Product Code
- OELLaser, Benign Prostatic Hyperplasia2Product Code
- OHOFirst Aid Kit Without Drug1Product Code
- OHSLight Based Over The Counter Wrinkle Reduction2Product Code
- OHTLight Based Over-The-Counter Hair Removal2Product Code
- OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption2Product Code
- OJJBurn Kit Without Drug1Product Code
- OJRVacuum Powered Body Fluid Collection Kit2Product Code
- OJTAspiration Tray1Product Code
- OJUSkin Prep Tray1Product Code
- OJVSingle Use Instrument Tray1Product Code
- OUHSkin Resurfacing Rf Applicator2Product Code
- OUPPowered Surgical Instrument For Improvement In The Appearance Of Cellulite2Product Code
- OJWShave Prep Kit2Product Code
- OKJLight Based Treatment For Cold Sores Herpes Simplex Virus-12Product Code
- OKONegative Pressure Wound Therapy Non-Powered Suction Apparatus2Product Code
- OLPOver-The-Counter Powered Light Based Laser For Acne2Product Code
- OMDCutaneous Tissue Adhesive With Mesh2Product Code
- OMPNegative Pressure Wound Therapy Powered Suction Pump2Product Code
- ONEPowered Light Based Non-Laser Surgical Instrument2Product Code
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect2Product Code
- ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output2Product Code
- ONQElectrosurgical Coagulation For Aesthetic2Product Code
- OOKDermal Cooling Pack/Vacuum/Massager2Product Code
- ORECryogenic, Skin Tag Removal, Otc2Product Code
- ORKLaser Assisted Lipolysis2Product Code
- OTKWound Drain Catheter System2Product Code
- OUBInstrument For Treatment Of Hyperhidrosis2Product Code
- OVNSuture Kit2Product Code
- OXTPercutaneous Surgical Set With Attachments2Product Code
- OYWLaser, Cellulite Appearance2Product Code
- PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction2Product Code
- PBXMassager, Vacuum, Radio Frequency Induced Heat2Product Code
- PBYTemporary Tissue Marker2Product Code
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- PDWInternal Tissue Marker2Product Code
- PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis2Product Code
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- PGZNon-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use2Product Code
- PJKTissue Adhesive For Internal Use3Product Code
- PKDLaceration Tray1Product Code
- PKELaparoscopic Cholecystectomy Kit1Product Code
- PKOTransparent Patch For Use In Treatment Of Tattoos2Product Code
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature2Product Code
- PMCScalp Cooling System2Product Code
- PMXAbsorbable Collagen Hemostatic Agent With Thrombin3Product Code
- PNLMagnetic Surgical System2Product Code
- PODTemporary, Internal Use Hemostatic2Product Code
- PQIWound Retraction And Protection System2Product Code
- PSNLight Based Imaging2Product Code
- PTXSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt2Product Code
- PUIDrape, Surgical, Exempt2Product Code
- PXNBasic Set-Up Tray1Product Code
- PXOBone Marrow Biopsy Tray1Product Code
- PXPBreast Biopsy / Localization Tray1Product Code
- QRLMultiple Use Blood Lancet For Single Patient Use Only2Product Code
- PXQBurn Dressing Tray1Product Code
- PXRCement And Bone Removal Kit1Product Code
- PXSCholecystectomy Kit1Product Code
- PXUFluid Drainage Tray1Product Code
- PXVGeneral Purpose Instrument Tray1Product Code
- PXWHerniorraphy Kit1Product Code
- PXXIncision Tray1Product Code
- PXYIrrigation Kit (Wounds)1Product Code
- PXZLaparascopic Sphincterotomy Kit1Product Code
- PYALiver Biopsy Kit1Product Code
- PYBMinor Surgical Procedures Tray1Product Code
- PYCParacentesis Tray1Product Code
- PYDPelviscopy Kit1Product Code
- PYEStaple Removal Kit1Product Code
- PYFSterile Puncture Tray1Product Code
- PYGSuction Catheter Kit1Product Code
- PYHSurgical Retractor Kit1Product Code
- PYIThoracic Catheter Insertion Tray1Product Code
- PYJUlcer Wound Tray1Product Code
- PYKVenous Ulcer Kit1Product Code
- PYLWound Drainage Kit1Product Code
- PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers2Product Code
- PZQGeneral Laparoscopic Power Morcellation Containment System2Product Code
- QAIPowered Microneedle Device2Product Code
- QAUHemostatic Device For Endoscopic Gastrointestinal Use2Product Code
- QCRWound Autofluorescence Imaging Device2Product Code
- QCYLaser Absorbing Particles2Product Code
- QDFParathyroid Autofluorescence Detection Device2Product Code
- QDGParathyroid Autofluorescence Imaging Device2Product Code
- QRMMultiple Use Blood Lancet For Multiple Patient Use3Product Code
- QFCNegative Pressure Wound Therapy Device For Reduction Of Wound Complications2Product Code
- QHFEnergy Based Device For Treatment Of Tattoos2Product Code
- QJFAutofluorescence Imaging Adjunct Tool For Wounds2Product Code
- QKLLipoaspirate Washing System For Aesthetic Body Contouring2Product Code
- QNMMountable Electromechanical Surgical System For Transluminal Approaches2Product Code
- QPBSystem, Suction, Lipoplasty For Removal2Product Code
- QPXNegative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical2Product Code
- QPZContact Cooling For Skin Lesion Pain Relief2Product Code
- RABSunlamp Products (Pre-Standard)2Product Code
- REFSuntan Bed2Product Code
- REGSuntan Lamp2Product Code
- REHTabletop Sunlamp System2Product Code
- QUBSuction Lipoplasty System For Removal And Transfer2Product Code
- QVJLow Power Electrosurgical Devices For Skin Lesion Destruction2Product Code
- QZNMulti-Photon Imaging2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K203024
- 510(k) Type
- Traditional
- Applicant
- PENTAX of America, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/24/2020
- Days to Decision
- 53 days
- Submission Type
- Summary