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
- K231240MaxTack™ Motorized Fixation Device2Cleared 510(K)
- K213271MedicloseTM System2Cleared 510(K)
- K231553OverStitch NXT Endoscopic Suturing System2Cleared 510(K)
- K211309endomina system2Cleared 510(K)
- K201744Su2ura Approximation Device2Cleared 510(K)
- K210266OverStitch Sx Endoscopic Suturing System2Cleared 510(K)
- K193652AbClose - Port Site Closure Device2Cleared 510(K)
- K191439OverStitch 2-0 Polypropylene Suture2Cleared 510(K)
- K181141OverStitch Endoscopic Suturing System and Accessories2Cleared 510(K)
- K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle2Cleared 510(K)
- K172666CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor2Cleared 510(K)
- K171886OverStitch SX Endoscopic Suturing System (ESS)2Cleared 510(K)
- K160117AbClose - Port Site Closure Device2Cleared 510(K)
- K160149Miret Grasper, Alligator, Miret Grasper, Maryland2Cleared 510(K)
- K132232MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM2Cleared 510(K)
- K132362WECK EFX ENDO FASCIAL CLOSURE SYSTEM2Cleared 510(K)
- K120147ACE STAPLER AND CARTRIDGE2Cleared 510(K)
- K110829ACE STAPLER AND CARTRIDGE2Cleared 510(K)
- K103412AXIOM FASCIAL CLOSURE SYSTEM2Cleared 510(K)
- K102931G-CINCH SUTURE GRASPER2Cleared 510(K)
- K101101MINI-TONG2Cleared 510(K)
- K082044ACE STAPLER, MODEL F00312Cleared 510(K)
- K091832ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER2Cleared 510(K)
- K090470AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES2Cleared 510(K)
- K090419SILS STITCH ENDOSCOPIC SUTURING DEVICE2Cleared 510(K)
- K082659MODIFIED ENDO STICH2Cleared 510(K)
- K081853OVERSTITCH ENDOSCOPIC SUTURE SYSTEM2Cleared 510(K)
- K073644ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES2Cleared 510(K)
- K073671PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE2Cleared 510(K)
- K070151INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER2Cleared 510(K)
- K070671OPUS SMARTSTITCH SUTURE DEVICE2Cleared 510(K)
- K070686MINI LAP INSTRUMENTS2Cleared 510(K)
- K070352MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM2Cleared 510(K)
- K062875ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES2Cleared 510(K)
- K062244OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR2Cleared 510(K)
- K061770ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM2Cleared 510(K)
- K033317SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-90702Cleared 510(K)
- K033269ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD2Cleared 510(K)
- K030170REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-85002Cleared 510(K)
- K023843SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE2Cleared 510(K)
- K022229SMARTSTITCH SUTURE DEVICE, MODEL OM-85002Cleared 510(K)
- K003949TACKER, MODEL R65-9332Cleared 510(K)
- K003102PARE ENDOSCOPIC SUTURING SYSTEM2Cleared 510(K)
- K002398ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING2Cleared 510(K)
- K000717SMITH & NEPHEW SUTURELOK, MODEL 72073212Cleared 510(K)
- K994087SUPERSTITCH2Cleared 510(K)
- K991500SMITH & NEPHEW SUTURE LOK2Cleared 510(K)
- K980815ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER2Cleared 510(K)
- K974137UROMED NEEDLE GRASPER2Cleared 510(K)
- K973313INNOVASIVE DEVICES Y-KNOT SUTURE CLIP2Cleared 510(K)
- K971939SMITH & NEPHEW SUTURE COLLET2Cleared 510(K)
- K970720ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER2Cleared 510(K)
- K963999AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE2Cleared 510(K)
- K962493ENDOSCOPIC CLIP APPLIER2Cleared 510(K)
- K961390ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER2Cleared 510(K)
- K960011ENDOSCOPIC NEEDLE DRIVER2Cleared 510(K)
- K954641ENDO-LEADER2Cleared 510(K)
- K955479KOH MICRO-SUTURING INSTRUMENTS2Cleared 510(K)
- K945202ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND RELOADING UNIT2Cleared 510(K)
- K944415ORIGIN TACKER SYSTEM2Cleared 510(K)
- K944435DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER2Cleared 510(K)
- K944292SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE2Cleared 510(K)
- K940967MODIFIED ENDOPATH ILS2Cleared 510(K)
- K935756ENDOSCOPIC ARTICULATING MULTI-FEED STAPLER WITH RELOAD UNIT2Cleared 510(K)
- K934738AUTOSUTURE ENDOSCOPIC SUTURING DEVICE2Cleared 510(K)
- K934174LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER2Cleared 510(K)
- K932434PROXIMATE ARTICULATING LINEAR STAPLER2Cleared 510(K)
- K935064ENDOPATH ENDOSCOPIC LINEAR CUTTER MODIFICATION2Cleared 510(K)
- 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
- 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
SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K023843
- 510(k) Type
- Traditional
- Applicant
- OPUS MEDICAL, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/14/2003
- Days to Decision
- 88 days
- Submission Type
- Statement