Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- FCPBox, Battery, Pocket1Product Code
- FCQLight Source, Incandescent, Diagnostic2Product Code
- EXQCystometer, Electrical Recording2Product Code
- EXRUrinometer, Mechanical2Product Code
- EXSUrinometer, Electrical2Product Code
- EXWPill, Radio2Product Code
- EXYUroflowmeter2Product Code
- EXZEquipment, Photographic, For Physiologic Function Monitor1Product Code
- FAJCystoscope And Accessories, Flexible/Rigid2Product Code
- FAKPanendoscope (Gastroduodenoscope)2Product Code
- FALPanendoscope (Urethroscope)2Product Code
- FAMSigmoidoscope And Accessories, Flexible/Rigid2Product Code
- FANSigmoidoscope, Rigid, Electrical2Product Code
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device2Product Code
- FBIRongeur, Cystoscopic2Product Code
- FBKEndoscopic Injection Needle, Gastroenterology-Urology2Product Code
- FBNCholedochoscope And Accessories, Flexible/Rigid2Product Code
- FBOCystourethroscope2Product Code
- FBPTelescope, Rigid, Endoscopic2Product Code
- FCCEndoscopic Magnetic Retriever2Product Code
- FCFInstrument, Biopsy, Mechanical, Gastrointestinal2Product Code
- FCGBiopsy Needle2Product Code
- FCIPunch, Biopsy2Product Code
- FCKInstrument, Biopsy, Suction2Product Code
- FCLForceps, Biopsy, Non-Electric1Product Code
- FCOBox, Battery, Rechargeable1Product Code
- FCRLight Source, Photographic, Fiberoptic2Product Code
- FCWLight Source, Fiberoptic, Routine2Product Code
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope2Product Code
- FCYBulb, Inflation, For Endoscope1Product Code
- FCZTube, Smoke Removal, Endoscopic1Product Code
- FDAEnteroscope And Accessories2Product Code
- FDCResectoscope, Working Element2Product Code
- FDELaparoscopy Kit2Product Code
- FDFColonoscope And Accessories, Flexible/Rigid2Product Code
- FDRSphyncteroscope2Product Code
- FDSGastroscope And Accessories, Flexible/Rigid2Product Code
- FDTDuodenoscope And Accessories, Flexible/Rigid2Product Code
- FDWEsophagoscope, Rigid, Gastro-Urology2Product Code
- FDXEndoscopic Cytology Brush2Product Code
- FDYDevice, Measuring, For Panendoscope1Product Code
- FDZAttachment, Eyepiece, For Insertion Of Prescription Lens1Product Code
- FEAAttachment, Teaching, For Endoscope1Product Code
- FECObturator, For Endoscope2Product Code
- FEDEndoscopic Access Overtube, Gastroenterology-Urology2Product Code
- K252572Prodeon Urethral Sheath System2Cleared 510(K)
- K250128Single Use Suction-Evacuation Ureteral Access Sheath2Cleared 510(K)
- K250132Ureteral Access Sheath2Cleared 510(K)
- K250695Single-use Ureteral Access Sheath2Cleared 510(K)
- K251599Single-use Ureteral Access Sheath2Cleared 510(K)
- K250585LumenaTM Ureteral Access Sheath2Cleared 510(K)
- K250452CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)2Cleared 510(K)
- K243710Disposable ureteral access sheath2Cleared 510(K)
- K250517Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M0062Cleared 510(K)
- K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-12502Cleared 510(K)
- K243025Ureteral Access Sheath2Cleared 510(K)
- K242173Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)2Cleared 510(K)
- K243091Over-tube (TR-1108A)2Cleared 510(K)
- K240167Single-use Ureteral Access Sheath2Cleared 510(K)
- K241181Disposable Ureteral Guide Sheath2Cleared 510(K)
- K240853Pathfinder® CR System2Cleared 510(K)
- K233472CVAC Aspiration System + CVAC Image Processor2Cleared 510(K)
- K230752Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)2Cleared 510(K)
- K230748Disposable Ureteral Access Sheath2Cleared 510(K)
- K230801Pathfinder Endoscope Overtube with Balloon Device2Cleared 510(K)
- K220065Single Use Ureteral Access Sheath2Cleared 510(K)
- K200770Mini PCNL-System2Cleared 510(K)
- K211301Pathfinder Endoscope Overtube2Cleared 510(K)
- K203165Disposable Ureteral Access Sheath2Cleared 510(K)
- K203119ClearPetra Suction-Evacuation Sheath2Cleared 510(K)
- K201815Dornier MAGELLAN Ureteral Access Sheath2Cleared 510(K)
- K200419Kalera Vacuum Aspiration Catheter (K-VAC)2Cleared 510(K)
- K192691PatCom Single-Use Introducer2Cleared 510(K)
- K191415Pathfinder Endoscope Overtube2Cleared 510(K)
- K191067Arc Endocuff Glide AEG110 & AEG1202Cleared 510(K)
- K182403Peel-Away Introducer2Cleared 510(K)
- K182520Flexible Overtube2Cleared 510(K)
- K190030Embrella Endoscopic Distal Attachment2Cleared 510(K)
- K181811ReTrace Ureteral Access Sheath2Cleared 510(K)
- K173400ORISE Tissue Retractor System2Cleared 510(K)
- K171208Trans-anal Introducer2Cleared 510(K)
- K172575BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap2Cleared 510(K)
- K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath2Cleared 510(K)
- K162205Arc EndoCuff and Arc EndoCuff Vision2Cleared 510(K)
- K161110ClearPetra Suction-Evacuation Sheath2Cleared 510(K)
- K160846AmplifEYE2Cleared 510(K)
- K160861Proxis Ureteral Access Sheath2Cleared 510(K)
- K151084Well Lead Ureteral Access Sheath2Cleared 510(K)
- K151801Arc Endocuff Vision2Cleared 510(K)
- K150083Sidecar External Working Channel2Cleared 510(K)
- K140523RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM2Cleared 510(K)
- K140323NAVIGATOR HD URETERAL ACCESS SHEATH SETS2Cleared 510(K)
- K131598ANAL RECTAL OVERTUBE2Cleared 510(K)
- K133359ENDORINGS2Cleared 510(K)
- K123013ENDOSCOPIC INTRODUCER2Cleared 510(K)
- K123675RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR2Cleared 510(K)
- K122649NAVIGATOR HD URETERAL ACCESS SHEATH SET2Cleared 510(K)
- K122270OVERTUBE ENDOSCOPIC ACCESS SYSTEM2Cleared 510(K)
- K120126BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE2Cleared 510(K)
- K122565ARC ENDOCUFF2Cleared 510(K)
- K110531ENDOFLIP ECD2Cleared 510(K)
- K102485RE-TRACE URETERAL ACCESS SHEATH2Cleared 510(K)
- K082102GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-002Cleared 510(K)
- K100081ENTEROSCOPY OVERTUBE, MODEL 007121402Cleared 510(K)
- K092221COLONIC SPLINTING OVERTUBE, MODEL 007111452Cleared 510(K)
- K092156CAD 12, COLONOSCOPY ASSIST DEVICE2Cleared 510(K)
- K091773FUJINON STERILE OVERTUBES2Cleared 510(K)
- K082589BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F00342Cleared 510(K)
- K080050SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE2Cleared 510(K)
- K072405USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE2Cleared 510(K)
- K062805MODIFICATION TO ENDO-EASE2Cleared 510(K)
- K061324EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-72Cleared 510(K)
- K061216USGI TRANSPORT ENDOSCOPIC GUIDE2Cleared 510(K)
- K052084ENDO-EASE ENDOSCOPIC OVERTUBE2Cleared 510(K)
- K051919MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE2Cleared 510(K)
- K051504SPYSCOPE ACCESS AND DELIVERY CATHETER2Cleared 510(K)
- K043418COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH2Cleared 510(K)
- K050253USGI SHAPELOCK ENDOSCOPIC GUIDE2Cleared 510(K)
- K040836DISPOSABLE OVERTUBE2Cleared 510(K)
- K033954SHAPE LOCKING ENDOSCOPIC OVERTUBE2Cleared 510(K)
- K033778MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT2Cleared 510(K)
- K023902SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE2Cleared 510(K)
- K030956NAVIGATOR URETERAL ACCESS SHEATH SET2Cleared 510(K)
- K030642DEFLECTING URETERAL ACCESS SHEATH2Cleared 510(K)
- K030438BARD AQUAGUIDE URETERAL CONDUIT2Cleared 510(K)
- K022686LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE2Cleared 510(K)
- K002018NDO SURGICAL SURGICAL OVERTUBE2Cleared 510(K)
- K993650URETERAL ACCESS SHEATH SET - NEW MODELS2Cleared 510(K)
- K990775URETERAL ACCESS SHEATH SET2Cleared 510(K)
- K983415DELIVERY SHEATH2Cleared 510(K)
- K973500BARD ENDOSCOPIC OVERTUBE (#000307)2Cleared 510(K)
- K972781OT-12Cleared 510(K)
- K942573COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH2Cleared 510(K)
- K942044BARD ENDOSCOPIC OVERTUBE2Cleared 510(K)
- K921120FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER2Cleared 510(K)
- K912265MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE10002Cleared 510(K)
- K903842ST-E1 OVERTUBE2Cleared 510(K)
- K896680PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.2Cleared 510(K)
- K890629ESOPHAGEAL OVERTUBE2Cleared 510(K)
- K841258FOREIGN BODY PROTECTOR2Cleared 510(K)
- K833268ENDOSCOPIC OVERTUBE2Cleared 510(K)
- K830247SPLIT COLON STIFFENING TUBE2Cleared 510(K)
- K813325KEY MED FOREIGN BODY REMOVAL TUBE2Cleared 510(K)
- K810180WILLIAMS OESOPHAGEAL VARICES INJECT TUBE2Cleared 510(K)
- FEIInstrument, Special Lens, For Endoscope1Product Code
- FEJAttachment, Binocular, For Endoscope1Product Code
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)1Product Code
- FENDevice, Cystometric, Hydraulic2Product Code
- FEQPump, Air, Non-Manual, For Endoscope2Product Code
- FERAnoscope And Accessories2Product Code
- FESRecorder, External, Pressure, Amplifier & Transducer2Product Code
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology2Product Code
- FFFCover, Biopsy Forceps1Product Code
- FFGDevice, Urine Flow Rate Measuring, Non-Electrical, Disposable2Product Code
- FFSImage, Illumination, Fiberoptic, For Endoscope2Product Code
- FFTElectrode, Ph, Stomach1Product Code
- FFXSystem, Gastrointestinal Motility (Electrical)2Product Code
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope1Product Code
- FFZCord, Electric, For Endoscope2Product Code
- FGAKit, Nephroscope2Product Code
- FGBUreteroscope And Accessories, Flexible/Rigid2Product Code
- FGCUrethroscope2Product Code
- FGSCarrier, Sponge, Endoscopic2Product Code
- FHOPneumoperitoneum Needle2Product Code
- FHPNeedle, Pneumoperitoneum, Simple2Product Code
- FHXJelly, Lubricating, For Transurethral Surgical Instrument2Product Code
- FJLResectoscope2Product Code
- FTILamp, Endoscope, Incandescent2Product Code
- FTJColonoscope, General & Plastic Surgery2Product Code
- GCFProctoscope2Product Code
- GCKGastroscope, General & Plastic Surgery2Product Code
- GCLEsophagoscope, General & Plastic Surgery2Product Code
- GCMEndoscope, Rigid2Product Code
- GCNEndoscope, Prism2Product Code
- GCOEndoscope, Mirror2Product Code
- GCPEndoscope, Ac-Powered And Accessories2Product Code
- GCQEndoscope, Flexible2Product Code
- GCSEndoscope, Battery-Powered And Accessories2Product Code
- GCTLight Source, Endoscope, Xenon Arc2Product Code
- GCWTransformer, Endoscope2Product Code
- GDBEndoscope, Fiber Optic2Product Code
- KDMSigmoidoscope, Rigid, Non-Electrical2Product Code
- KDORongeur, Cystoscopic, Hot2Product Code
- KGDScissors For Cystoscope2Product Code
- KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube2Product Code
- KNWInstrument, Biopsy2Product Code
- MNKEndoscopic Bite Block1Product Code
- MNLAccessories, Cleaning Brushes, For Endoscope1Product Code
- MYESystem, Electrogastrography (Egg)2Product Code
- NBGMarker, Colon2Product Code
- NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule2Product Code
- NLMLaparoscope, General & Plastic Surgery, Reprocessed2Product Code
- NLSInstrument, Biopsy, Reprocessed2Product Code
- NLXNeedle, Pneumoperitoneum, Spring Loaded, Reprocessed2Product Code
- NMXNeedle And Needle Set, Gastro-Urology, Reprocessed2Product Code
- NMYNeedle, Endoscopic, Reprocessed2Product Code
- NONForceps, Biopsy, Non-Electric, Reprocessed1Product Code
- NSISystem, Imaging, Esophageal, Wireless, Capsule2Product Code
- NTNLed Light Source2Product Code
- NWBEndoscope, Accessories, Narrow Band Spectrum2Product Code
- NYVGastrointestinal Motility System, Capsule2Product Code
- NWSKit, Choledochoscope, Flexible And Rigid2Product Code
- NWTEndoscopic Cholangiogram Kit2Product Code
- NWUEndoscope Introducer Kit2Product Code
- OCSEndoscopic Video Imaging System/Component, Gastroenterology-Urology2Product Code
- OCTAnti Fog Solution And Accessories, Endoscopy2Product Code
- OCUEndoscopic Storage Cover2Product Code
- OCVEndoscope Holder2Product Code
- OCWEndoscopic Tissue Approximation Device2Product Code
- OCXEndoscopic Irrigation/Suction System2Product Code
- OCYEndoscopic Guidewire, Gastroenterology-Urology2Product Code
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered2Product Code
- ODAEndoscopic Central Control Unit2Product Code
- ODBEndoscopic Contamination Prevention Sheath2Product Code
- ODCEndoscope Channel Accessory2Product Code
- ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula2Product Code
- ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)2Product Code
- ODFMini Endoscope, Gastroenterology-Urology2Product Code
- ODGEndoscopic Ultrasound System, Gastroenterology-Urology2Product Code
- PCVEndoscopic Leak Tester2Product Code
- PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement2Product Code
- PGDColon Capsule Imaging System2Product Code
- PGUSpatial Imaging For Display Of Endoscope Position2Product Code
- PHTBasin For Endoscope Reprocessing1Product Code
- PLLSubmucosal Injection Agent2Product Code
- POZBiopsy Needle Kit2Product Code
- PPENephroscope Set2Product Code
- PRVGastro-Urology Biopsy Kit2Product Code
- PTQEndoscopic Magnetic Retriever, Exempt2Product Code
- QFZGastroenterology-Urology Accessories To A Biopsy Instrument1Product Code
- PTRScissors For Cytoscope, Exempt2Product Code
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt2Product Code
- QIJEndoscopic Transhepatic Venous Access Needle2Product Code
- QISEsophageal, Mucosal, Electrical Characterization2Product Code
- QKZMagnetically Maneuvered Capsule Endoscopy System2Product Code
- QNPGastrointesinal Lesion Software Detection System2Product Code
- SBXSoftware For Endoscopy Procedure Metrics2Product Code
- SGHUltrasound Imaging For Vascular Access For Hemodialysis2Product Code
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- 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
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Kalera Vacuum Aspiration Catheter (K-VAC)
- Page Type
- Cleared 510(K)
- 510(k) Number
- K200419
- 510(k) Type
- Traditional
- Applicant
- Kalera Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/22/2020
- Days to Decision
- 92 days
- Submission Type
- Summary