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
- K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)2Cleared 510(K)
- K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)2Cleared 510(K)
- K243276ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)2Cleared 510(K)
- K241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)2Cleared 510(K)
- K242679Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)2Cleared 510(K)
- K222487Anika Tissue Tack Fixation System2Cleared 510(K)
- K222210AEON Endoscopic Stapler2Cleared 510(K)
- K223760ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)2Cleared 510(K)
- K211197Disposable Endoscopic Cutter Stapler and Cartridge2Cleared 510(K)
- K221771EEA Circular Stapler with Tri-Staple Technology2Cleared 510(K)
- K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip Version2Cleared 510(K)
- K221003Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA2Cleared 510(K)
- K221013GIA Auto Suture Stapler with DST Series Technology2Cleared 510(K)
- K221006GIA Stapler with Tri-Staple Technology2Cleared 510(K)
- K221005EEA Circular Stapler with Tri-Staple Technology2Cleared 510(K)
- K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers2Cleared 510(K)
- K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers2Cleared 510(K)
- K201934Surgimatix Absorbable Fixation System2Cleared 510(K)
- K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use2Cleared 510(K)
- K201639Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads2Cleared 510(K)
- K202709Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges2Cleared 510(K)
- K210278Titan SGS2Cleared 510(K)
- K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload2Cleared 510(K)
- K202507EEA Circular Stapler with Tri-Staple Technology2Cleared 510(K)
- K203117TissueTak device2Cleared 510(K)
- K202467Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads2Cleared 510(K)
- K202701GIA Stapler with Tri-Staple Technology2Cleared 510(K)
- K202864Tri-Staple 2.0 Reloads2Cleared 510(K)
- K202665Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm2Cleared 510(K)
- K201882AEON Endoscopic Stapler2Cleared 510(K)
- K201280Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed2Cleared 510(K)
- K201672Signia Stapler (with new software)2Cleared 510(K)
- K200420Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green2Cleared 510(K)
- K192720GIA Stapler with Tri-Staple Technology2Cleared 510(K)
- K192330EEA Circular Stapler with Tri-Staple Technology2Cleared 510(K)
- K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool2Cleared 510(K)
- K182476Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads2Cleared 510(K)
- K190331Applied Medical Laparoscopic Linear Cutter2Cleared 510(K)
- K192566Reach and CQ'ENCE Circular Staplers2Cleared 510(K)
- K191070Signia Small Diameter Reloads2Cleared 510(K)
- K191287OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners2Cleared 510(K)
- K182217Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use2Cleared 510(K)
- K182475Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)2Cleared 510(K)
- K181668FasTouch Absorbable Fixation System2Cleared 510(K)
- K183477easyPPHTM Hemorrhoidal Stapler for Single Use2Cleared 510(K)
- K183435Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black2Cleared 510(K)
- K181657easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use2Cleared 510(K)
- K180175SignalMark Lung Biopsy Site Marker2Cleared 510(K)
- K182380AEON Endoscopic Stapler2Cleared 510(K)
- K181653Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed2Cleared 510(K)
- K181620Endoscopic Linear Cutting Staplers and Loading Units for Single Use2Cleared 510(K)
- K173270Tri-Staple 2.0 Reinforced Reload2Cleared 510(K)
- K172361EEA Circular Stapler with Tri-Staple Technology2Cleared 510(K)
- K173443AEON Endoscopic Stapler2Cleared 510(K)
- K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use2Cleared 510(K)
- K172561Disposable Circular Stapler2Cleared 510(K)
- K172538Disposable Linear Stapler, Disposable Linear Cutter2Cleared 510(K)
- K171589AEON Endoscopic Stapler2Cleared 510(K)
- K171561Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload2Cleared 510(K)
- K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload2Cleared 510(K)
- K170278OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners2Cleared 510(K)
- K163523ECHELON CIRCULAR Powered Stapler2Cleared 510(K)
- K163698OptiFix Open Absorbable Fixation System - 20 absorbable fasteners2Cleared 510(K)
- K162947Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler2Cleared 510(K)
- K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)2Cleared 510(K)
- K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload2Cleared 510(K)
- K163454ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm2Cleared 510(K)
- K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler2Cleared 510(K)
- K163098Tri-Staple 2.0 Intelligent Cartridge2Cleared 510(K)
- K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads2Cleared 510(K)
- K161905Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge2Cleared 510(K)
- K162252FasTouch Fixation System2Cleared 510(K)
- K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload2Cleared 510(K)
- K160900CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners2Cleared 510(K)
- K160176Signia Stapler2Cleared 510(K)
- K153202iMESH Tacker2Cleared 510(K)
- K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm2Cleared 510(K)
- K151081MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge2Cleared 510(K)
- K152618PANTHER Cutter Stapler2Cleared 510(K)
- K151659ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks2Cleared 510(K)
- K142577PANTHER Endo Linear Cutter Staplers with Single Use Loading Units2Cleared 510(K)
- K151163Signia Loading Unit, Tri-Staple 2.0 Cartridge2Cleared 510(K)
- K150026Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler2Cleared 510(K)
- K142873OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners2Cleared 510(K)
- K142808CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners2Cleared 510(K)
- K143129easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)2Cleared 510(K)
- K141952ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED2Cleared 510(K)
- K141097CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE2Cleared 510(K)
- K141367LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS2Cleared 510(K)
- K140560ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING2Cleared 510(K)
- K140609RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS2Cleared 510(K)
- K131563SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM2Cleared 510(K)
- K132698FASTOUCH FIXATION SYSTEM2Cleared 510(K)
- K140118MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE2Cleared 510(K)
- K140170MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE2Cleared 510(K)
- K132472JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD2Cleared 510(K)
- K133938ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY2Cleared 510(K)
- K133499SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA2Cleared 510(K)
- K132669PROXIFAST ABSORBABLE STAPLE2Cleared 510(K)
- K133762ENDO GIA(TM) EXTRA LONG ADAPTER2Cleared 510(K)
- K132581MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE2Cleared 510(K)
- K130738ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS2Cleared 510(K)
- K132134OPTIFIX ABSORBABLE FIXATION SYSTEM2Cleared 510(K)
- K132493ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY2Cleared 510(K)
- K131663ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK2Cleared 510(K)
- K131637ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)2Cleared 510(K)
- K131511DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR2Cleared 510(K)
- K131705ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY2Cleared 510(K)
- K131303DISPOSABLE CIRCULAR STAPLER2Cleared 510(K)
- K130717ENDO GIA RELOAD2Cleared 510(K)
- K130653ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU2Cleared 510(K)
- K123114ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE2Cleared 510(K)
- K122781RELIAMAX GASTROINTESTINAL ANASTOMOSIS AND RELOAD2Cleared 510(K)
- K123718PERMASORB DISPOSABLE FIXATION DEVICE2Cleared 510(K)
- K123318IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER2Cleared 510(K)
- K123109ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE2Cleared 510(K)
- K121510IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER2Cleared 510(K)
- K121600ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE2Cleared 510(K)
- K121474DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER2Cleared 510(K)
- K120179REACH SURGICAL STAPLERS2Cleared 510(K)
- K120373INSORB ABSORBALBE STAPLE2Cleared 510(K)
- K120258DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS2Cleared 510(K)
- K120268AMID STAPLER2Cleared 510(K)
- K112056ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL2Cleared 510(K)
- K111825ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS2Cleared 510(K)
- K111195VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS2Cleared 510(K)
- K111111ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO2Cleared 510(K)
- K110728IMESH TACKER2Cleared 510(K)
- K111153SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM2Cleared 510(K)
- K111064TIGERPAW SYSTEM II2Cleared 510(K)
- K103672REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET2Cleared 510(K)
- K110385ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER2Cleared 510(K)
- K110049REUSABLE LINEAR STAPLER HANDLE2Cleared 510(K)
- K103470PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP2Cleared 510(K)
- K103263ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY2Cleared 510(K)
- K101961TIGERPAW SYSTEM2Cleared 510(K)
- K102325IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)2Cleared 510(K)
- K102632ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER2Cleared 510(K)
- K102291COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY2Cleared 510(K)
- K101378FRANKENMAN SURGICAL STAPLERS2Cleared 510(K)
- K101444AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY2Cleared 510(K)
- K100723DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.52Cleared 510(K)
- K093845ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP252Cleared 510(K)
- K100386DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 322Cleared 510(K)
- K092483BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 01160182Cleared 510(K)
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- 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
- SFGCamera, Surgical, Measurement1Product Code
- SGVAgent, Absorbable Hemostatic, Collagen With Polymeric Additives3Product 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
Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K161137
- 510(k) Type
- Traditional
- Applicant
- Cardica, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/20/2016
- Days to Decision
- 89 days
- Submission Type
- Summary