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
- 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
- K242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)2Cleared 510(K)
- K191900Single Use Grasping Forceps2Cleared 510(K)
- K152802Grasping Forceps2Cleared 510(K)
- K150939Ensizor Endoscopic Scissors2Cleared 510(K)
- K141058ENSIZOR ENDOSCOPIC SCISSORS2Cleared 510(K)
- K133736ENDOSCOPIC SUTURE CUTTER2Cleared 510(K)
- K120084ENDOSCOPIC RETRIEVAL DEVICE2Cleared 510(K)
- K103688G-PROX EZ ENDOSCOPIC GRASPER2Cleared 510(K)
- K101298ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS2Cleared 510(K)
- K072684MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM2Cleared 510(K)
- K051276HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM2Cleared 510(K)
- K012074XBO1-824-18/19/20 BIOPSY FORCEPS2Cleared 510(K)
- K010412FLEXIBLE ENDOSCOPIC SCISSORS2Cleared 510(K)
- K974300TELEMED SYSTEMS RETRIEVAL BASKET2Cleared 510(K)
- K973071TRI TALON RETRIEVAL FORCEPS2Cleared 510(K)
- K973259K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)2Cleared 510(K)
- K971123STONE EXTRACTOR2Cleared 510(K)
- K971202COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS2Cleared 510(K)
- K970982T-RX RETRIEVAL FORCEPS2Cleared 510(K)
- K965176PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS2Cleared 510(K)
- K961611OLYMPUS BASKET GRASPERS (UROLOGY)2Cleared 510(K)
- K955066OLYMPUS FG SERIES GRASPING FORCEPS2Cleared 510(K)
- K955063OLYMPUS BASKET GRASPERS2Cleared 510(K)
- K955051OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS2Cleared 510(K)
- K954536BLADE, SCALPEL & BLADE, HANDEL2Cleared 510(K)
- K950434KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES2Cleared 510(K)
- K943476GIP/MEDI-GLOBE GOREIGN BODY GRASPERS2Cleared 510(K)
- K941464BASICS ENDOSCOPY SYSTEM2Cleared 510(K)
- K942030BIOPSY SCISSORS2Cleared 510(K)
- K930499GRASPING FORCEPS FLEXIBLE STONE DISLODGER2Cleared 510(K)
- K923489COX DISPOSABLE RETRIEVAL DEVICES2Cleared 510(K)
- K920762BIOSPSY FORCEPS2Cleared 510(K)
- K914503GRASPING FORCEPS2Cleared 510(K)
- K902949CORPAK GRASPING FORCEPS2Cleared 510(K)
- K902400WILSON-COOK RETRIEVAL & GRASPING FORCEPS2Cleared 510(K)
- K896502PORGES BIOPSY & FOREIGN BODY FORCEPS2Cleared 510(K)
- K894862WILTEK GRASPING FORCEPS2Cleared 510(K)
- K8949863-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET2Cleared 510(K)
- K881332DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH2Cleared 510(K)
- K8813993 FRENCH FLEXIBLE BIOPSY FORCEPS2Cleared 510(K)
- K873248GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS2Cleared 510(K)
- K874015HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 23/12)2Cleared 510(K)
- K874003HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 18/12)2Cleared 510(K)
- K874004ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125)2Cleared 510(K)
- K874005RAT TOOTH GRASPING FORCEP (MODEL 23/20)2Cleared 510(K)
- K874006GRASPING TRIPOD FORCEP (MODEL 23/25)2Cleared 510(K)
- K874007OVAL CUP HOT BIOPSY FORCEP (MODEL A-51)2Cleared 510(K)
- K874008OVAL CUP HOT BIOPSY FORCEP (MODEL B-51)2Cleared 510(K)
- K874009OVAL CUP HOT BIOPSY FORCEP (MODEL C-52)2Cleared 510(K)
- K874010ROUND CUP HOT BIOPSY FORCEP (MODEL D-52)2Cleared 510(K)
- K874011OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1)2Cleared 510(K)
- K874012OVAL CUP BIOPSY FORCEP (MODEL 18/5)2Cleared 510(K)
- K874013OVAL CUP BIOPSY FORCEP(23/5) USED W/COLONOSCOPE2Cleared 510(K)
- K874014OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1)2Cleared 510(K)
- K874016OVAL CUP BIOPSY FORCEP(23/5) USED W/GASTRO/SIGOIDO2Cleared 510(K)
- K871809FLEXIBLE BIOPSY FORCEP2Cleared 510(K)
- K870355(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE2Cleared 510(K)
- K865087VAN-TEC DOUBLE SHEATH GRASPING FORCEPS2Cleared 510(K)
- K845017DAVOL RETRIEVAL BASKETS & FORCEPS2Cleared 510(K)
- K844074HOBBS MEDICAL POLYPECTOMY SNARE2Cleared 510(K)
- K840800POLYP-SAVER SLEVE2Cleared 510(K)
- K833124HOBBS MEDICAL RETRIEVAL BASKET2Cleared 510(K)
- K833125HOBBS MEDICAL GRASPING FORCEPS2Cleared 510(K)
- K830802LOOP RETRIEVER2Cleared 510(K)
- K820429SPIRAL STONE AND RETRIEVAL BASKETS2Cleared 510(K)
- K800976M.R. ASSOC. W TYPE GRASPING FORCEPS2Cleared 510(K)
- K800968M.R. ASSOC. RAT TOOTH GRASP FORCEPS2Cleared 510(K)
- K800967M.R. ASSOC. ALLIGATOR GRASPONG FORCEPS2Cleared 510(K)
- K800972M.R. ASSOC. TRIPOD GRASPING FORCEPS2Cleared 510(K)
- K800970M.R. ASSOC. BASKET RETRIEVERS2Cleared 510(K)
- K800969M.R. ASSOC. CANNULAS2Cleared 510(K)
- K792345RETRIEVABLE FORCEPS2Cleared 510(K)
- K760180FORCEPS, GRASPING2Cleared 510(K)
- 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
BLADE, SCALPEL & BLADE, HANDEL
- Page Type
- Cleared 510(K)
- 510(k) Number
- K954536
- 510(k) Type
- Traditional
- Applicant
- ACCESS SURGICAL INTL., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/29/1995
- Days to Decision
- 61 days
- Submission Type
- Summary