Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- 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
- FADStent, Ureteral2Product Code
- EXXProbe, Rectal, Non-Powered1Product Code
- EYDStirrups1Product Code
- EYHTable, Cysto, Non-Electrical1Product Code
- EYSRibdam1Product Code
- EZOUrethrotome2Product Code
- EZPRod, Colostomy2Product Code
- FARUnit, Electrosurgical2Product Code
- FASElectrode, Electrosurgical, Active, Urological2Product Code
- FBJCord, Electric For Transurethral Surgical Instrument2Product Code
- FBSSound, Metal, Interconnected1Product Code
- FCHTray, Biopsy, Without Biopsy Instruments1Product Code
- FCSLight, Catheter, Fiberoptic, Glass, Ureteral2Product Code
- FDBPlate, Patient2Product Code
- FDGRetractor, Fiberoptic1Product Code
- FDISnare, Flexible2Product Code
- FDJSnare, Rigid Self-Opening2Product Code
- FDLWristlet, Patient Return2Product Code
- FEHElectrode, Flexible Suction Coagulator2Product Code
- FEOLithotriptor, Ultrasonic2Product Code
- FFDEvacuator, Bladder, Manually Operated1Product Code
- FFESystem, Water Jet Catheter, Renal2Product Code
- FFISystem, Alarm, Electrosurgical2Product Code
- FFKLithotriptor, Electro-Hydraulic2Product Code
- FFLDislodger, Stone, Basket, Ureteral, Metal2Product Code
- FFNClamp, Non-Electrical1Product Code
- FFORetractor, Self-Retaining1Product Code
- FFQSpeculum, Rectal1Product Code
- FFRDevice, Locking, For Intestinal Clamp1Product Code
- FGKTripsor, Stone, Bladder2Product Code
- FGMProbe And Director, Gastro-Urology1Product Code
- FGNRetractor, Non-Self-Retaining1Product Code
- FGODislodger, Stone, Flexible2Product Code
- FGWClamp, Electrical2Product Code
- FGXSnare, Non-Electrical1Product Code
- FHBHook, Gastro-Urology1Product Code
- FHCAdaptor To The Cord, For Transurethral Surgical Instrument2Product Code
- FHFSystem, Evacuator, Fluid2Product Code
- FHHCrusher, Spur, Colostomy1Product Code
- FHIRing, Laparotomy1Product Code
- FHKSpreader, Bladder Neck1Product Code
- FHLScoop1Product Code
- FHNLigator, Hemorrhoidal2Product Code
- FHQHolder, Needle, Gastroenterologic1Product Code
- FHYJelly, Contact, For Transurethral Surgical Instrument2Product Code
- FHZDesiccator, Transurethral2Product Code
- FKKClamp, Line1Product Code
- KGEForceps, Biopsy, Electric2Product Code
- K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)2Cleared 510(K)
- K242857ClearHemograsper2Cleared 510(K)
- K231721Disposable Hot Biopsy Forceps2Cleared 510(K)
- K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI2Cleared 510(K)
- K210406Bipolar Coagulation Foreceps2Cleared 510(K)
- K202438Ensure Single-Use Coagulation Forceps2Cleared 510(K)
- K183428Avulsion Forceps2Cleared 510(K)
- K180018Disposable Hot Biopsy Forceps2Cleared 510(K)
- K180134Ensizor Monopolar Endoscopic Scissors2Cleared 510(K)
- K171973Captura® Disposable Hot Biopsy Forceps2Cleared 510(K)
- K171916Single Use Hot Biopsy Forceps FD-2312Cleared 510(K)
- K171096Fujifilm Diathermic Slitter (FlushKnife)2Cleared 510(K)
- K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)2Cleared 510(K)
- K160625Disposable Hot Biopsy Forceps2Cleared 510(K)
- K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)2Cleared 510(K)
- K141794ENDO-MARYLAND DISSECTOR2Cleared 510(K)
- K131991ENDOCHOICE HOT BIOPSY FORCEPS2Cleared 510(K)
- K101657RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 402Cleared 510(K)
- K090796MULTI-BITE HOT BIOPSY FORCEPS2Cleared 510(K)
- K090583ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-1652Cleared 510(K)
- K062517ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES2Cleared 510(K)
- K022751REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS2Cleared 510(K)
- K022243HORIZONS REUSABLE HOT BIOPSY FORCEPS2Cleared 510(K)
- K021706HORIZONS HOT BIOPSY FORCEPS2Cleared 510(K)
- K000086WILSON-COOK REUSABLE HOT BIOPSY FORCEPS2Cleared 510(K)
- K992390HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD2Cleared 510(K)
- K990231WILTEK HOT BIOPSY FORCEPS2Cleared 510(K)
- K983811UNIPOLAR OPTICAL BIOPSY FORCEPS2Cleared 510(K)
- K972505RESUABLE HOT BIOPSY FORCEPS2Cleared 510(K)
- K970083DYNABITE HOT GI BIOPSY FORCEPS2Cleared 510(K)
- K971204LSVP INTERNATIONAL HOT BIOPSY FORCEPS2Cleared 510(K)
- K953355GIP/MEID-GLOBE HOT BIOPSY FORCEPS2Cleared 510(K)
- K955052OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS2Cleared 510(K)
- K951445OLYMPUS FD-5 HOT BIOPSY FORCEPS2Cleared 510(K)
- K944765KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS2Cleared 510(K)
- K943078HOT BIOPSY FORCEPS2Cleared 510(K)
- K940911BASICS ENDOSCOPY SYSTEM2Cleared 510(K)
- K932266SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN2Cleared 510(K)
- K932790THERMAL OPTION2Cleared 510(K)
- K923470DISPOSABLE HOT BIOPSY FORCEPS2Cleared 510(K)
- K925361BIOPSY FORCEPS, ELECTRIC2Cleared 510(K)
- K910964HOT BIOPSY FORCEPS2Cleared 510(K)
- K905088HOT BIOPSY FORCEPS2Cleared 510(K)
- K904985BIPOLAR BIOPSY FORCEPS2Cleared 510(K)
- K896537PORGES HOT BIOPSY FORCEPS2Cleared 510(K)
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)2Product Code
- KOASurgical Instruments, G-U, Manual (And Accessories)1Product Code
- KQSTable, Cystometric, Non-Electric And Accessories1Product Code
- KQTEvacuator, Gastro-Urology2Product Code
- LQCLithotriptor, Biliary Mechanical2Product Code
- MMZTable, Cystometric, Electric2Product Code
- MNDLigator, Esophageal2Product Code
- NLRUnit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed2Product Code
- NLTSnare, Flexible, Reprocessed2Product Code
- NLUForceps, Biopsy, Electric, Reprocessed2Product Code
- NLVElectrode, Flexible Suction Coagulator, Reprocessed2Product Code
- NLWElectrode, Electrosurgical, Active, Urological, Reprocessed2Product Code
- NQTDislodger, Stone, Flexible, Ureteral, Reprocessed2Product Code
- NQUDislodger, Stone, Basket, Ureteral, Metal, Reprocessed2Product Code
- NWIElectrosurgical Electrode Kit2Product Code
- OLHOrchidometer1Product Code
- ONJDissolvable Gel For Preventing Ureteral Stone Migration2Product Code
- OOWApplicator For Rectal Suppository1Product Code
- PKLHemostatic Metal Clip For The Gi Tract2Product Code
- PLPHigh Intensity Ultrasound System For Prostate Tissue Ablation2Product Code
- PRUGastric Lavage Kit (Adult Or Pediatric Use)2Product Code
- QGBUreteral Stent Accessories1Product Code
- PVYVasovasostomy Set1Product Code
- QNEEndoscopic Pancreatic Debridement Device2Product Code
- QAGEndoscopic Electrosurgical Clip Cutting System2Product Code
- LNKLaser For Gastro-Urology Use2Product Code
- MUKElectrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue2Product Code
- NEJSystem, Cryosurgical, Liquid Nitrogen, For Gastroenterology2Product Code
- PZPFluid Jet Removal System2Product Code
- 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
Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)
- Page Type
- Cleared 510(K)
- 510(k) Number
- K161186
- 510(k) Type
- Special
- Applicant
- FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/29/2016
- Days to Decision
- 63 days
- Submission Type
- Summary