Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 36
- Latest Decision
- 1993-12-27
Clearances · page 74 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K932692 | INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT | Innerdyne Medical, Inc. | GCJ | Class II | 1993-12-27 |
| K933724 | SENSOR-TIP TROCAR | Origin Medsystems, Inc. | GCJ | Class II | 1993-12-27 |
| K934739 | DAVINCI CHOLANGIOGRAM DELIVERY DEVICE | Da Vinci Medical, Inc. | GCJ | Class II | 1993-12-23 |
| K920664 | DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION | Diagnostic Ultrasound Corp. | FFX | Class II | 1993-12-23 |
| K934724 | AESCULAP TROCAR INSTRUMENT SET | Aesculap, Inc. | FBQ | Class II | 1993-12-23 |
| K934163 | WATTS RAKE DEVICE | Phx Technologies Corp. | GCJ | Class II | 1993-12-22 |
| K931195 | PERCUTANEOUS DRAINAGE LOOP CATHETER SET | Cook Urological, Inc. | KOD | Class II | 1993-12-22 |
| K935059 | INSUFFLATION TUBING SET, PHX500-082 | Phx Technologies Corp. | FCX | Class II | 1993-12-22 |
| K933992 | OLYMPUS SCLEROTHERAPY BALLOON | Olympus Corp. | KNQ | Class II | 1993-12-21 |
| K933834 | AESCULAP RIGID ENDOSCOPES | Aesculap, Inc. | GCJ | Class II | 1993-12-20 |
| K926181 | ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY | Zinnanti Surgical Instruments, Inc. | GCJ | Class II | 1993-12-17 |
| K934027 | PHX TECHNOLOGIES CORP., ALLIGATOR GRASPER DEVICE | Phx Technologies Corp. | GCJ | Class II | 1993-12-17 |
| K934025 | PHX TECHNOLOGIES CORP, SPONGE GRASPER DEVICE | Phx Technologies Corp. | GCJ | Class II | 1993-12-17 |
| K935578 | URINE METER | Puritas Health Care, Inc. | EXR | Class II | 1993-12-17 |
| K934021 | PHX TECHNOLOGIES CORP., BOWEL GRASPER DEVICE | Phx Technologies Corp. | GCJ | Class II | 1993-12-17 |
| K934803 | ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS | Baxter Healthcare Corp | FJK | Class II | 1993-12-17 |
| K934026 | PHX TECHNOLOGIES CORP. BOWEL GRASPER DEVICE | Phx Technologies Corp. | GCJ | Class II | 1993-12-17 |
| K934023 | PHX TECHNOLOGIES CORP., ALTRAUMATIC GRASPER DEVICE | Phx Technologies Corp. | GCJ | Class II | 1993-12-17 |
| K934024 | PHX TECHNOLOGIES CORP., SUTURE GRASPER DEVICE | Phx Technologies Corp. | GCJ | Class II | 1993-12-17 |
| K934078 | PHX TECHNOLOGIES CORP.,10MM STERILE, DISPOSABLE POOL TIP SUCTION CANNULA | Phx Technologies Corp. | GCJ | Class II | 1993-12-17 |
| K934022 | PHX TECH SINGLE ACTION HEAVY-TOOTH JAW CLAW GRASPER | Phx Technologies Corp. | GCJ | Class II | 1993-12-17 |
| K934185 | TROCAR REDUCER WITH GAS CLHECK VALVE | Phx Technologies Corp. | GCJ | Class II | 1993-12-16 |
| K934098 | STERILE, DISPOSABLE ENDOSCOPIC TRUMPET VALVE | Phx Technologies Corp. | GCJ | Class II | 1993-12-16 |
| K934186 | FORCEPS, BIOPSY, GASTROINTESTINAL | Primed Instruments, Inc. | FCL | Class I | 1993-12-14 |
| K914793 | MONOCRYSTANT PH/LES CATHETER, MODIFICATION | Synectics-Dantec | KLA | Class II | 1993-12-13 |
| K933812 | ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES | Advanced Surgical, Inc. | GCJ | Class II | 1993-12-13 |
| K931962 | NON-ABSORBABLE GAUZE | United States Surgical, A Division of Tyco Healthc | GCJ | Class II | 1993-12-10 |
| K933896 | PHX TECHNOLOGIES CORP., MONOPOLAR ELECTROCAUTERY PROBE TIP CLEANER | Phx Technologies Corp. | GCJ | Class II | 1993-12-09 |
| K933897 | PHX TECHNOLOGIES CORP., 5MM DISPOSABLE SUCTION-IRRIGATION CANNULA CLEANER | Phx Technologies Corp. | GCJ | Class II | 1993-12-09 |
| K932321 | LAPAROSCOPY OPTICS | Medline Industries, Inc. | GCJ | Class II | 1993-12-09 |
| K934534 | TROCAR W/CANNULA, O RING, ADAPTER, AND ADAPTER SLEEVE MODIFICATION | Baxter Healthcare Corp | GCJ | Class II | 1993-12-07 |
| K923729 | URETERAL CATHETER | Cook Urological, Inc. | EYB | Class II | 1993-12-07 |
| K920703 | GASTROINTESTINAL FEEDING TUBE | Wilson-Cook Medical, Inc. | KNT | Class II | 1993-12-03 |
| K922998 | ENFUSE ENTERAL FEEDING TUBE | Rusch, Inc. | KNT | Class II | 1993-12-03 |
| K915620 | ENDOWASH | Novar Medical Industries | FEB | Class II | 1993-12-02 |
| K921134 | FRESENIUS POLYSULFONE DIALYZERS | Fresenius USA, Inc. | KDI | Class II | 1993-12-02 |
| K934623 | ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA | Endomedix | FET | Class II | 1993-12-02 |
| K933815 | BARD ENDOSCOPIC INJECTION SYSTEM | C.R. Bard, Inc. | FBK | Class II | 1993-12-01 |
| K932143 | FLEXI-TRAK ANCHORING DEVICE | Convatec, A Division of E.R. Squibb & Sons | KNY | Class II | 1993-12-01 |
| K922667 | MIC LOW PROFILE GASTROSTOMY TUBE | Medical Innovations Corp. | KNT | Class II | 1993-12-01 |
| K934173 | SUTURE HANDLER | Surgin Surgical Instrumentation, Inc. | GCJ | Class II | 1993-12-01 |
| K934369 | DRI SLEEPER | Laborie Medical Technologies, Ltd. | KPN | Class II | 1993-11-24 |
| K931783 | AESOP (AUTOMATED ENDOSCOPIC SYSTEM FOR OPTIMAL POS | Computer Motion, Inc. | GCJ | Class II | 1993-11-22 |
| K934683 | R AND D BATERIES | R & D Batteries, Inc. | FCO | Class I | 1993-11-22 |
| K933536 | CARTER-THOMASON NEEDLE-POINT SUTURE PASSER | Neimark Labs, Inc. | GCJ | Class II | 1993-11-22 |
| K934141 | STAND ALONE CYSTOMETROGRAM | Medical Engineering Corp. | FEN | Class II | 1993-11-18 |
| K934725 | PHX TECHNOLOGIES CORP., ISDS-2000, IRRIGATION SOLUTION DELIVERY SYSTEM | Phx Technologies Corp. | GCJ | Class II | 1993-11-18 |
| K931179 | UROLAB SPECTRUM | Life-Tech Intl., Inc. | FAP | Class II | 1993-11-18 |
| K934076 | PHX TECHNOLOGIES CORP., IRRIGATION SOLUTION DELIVERY SYSTEM, ISDS-1000 | Phx Technologies Corp. | GCJ | Class II | 1993-11-18 |
| K933192 | ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST. | Access Surgical Intl., Inc. | GCJ | Class II | 1993-11-18 |
| K933957 | DILATING URETHRAL SOUND | Cook Urological, Inc. | FAH | Class II | 1993-11-17 |
| K930456 | INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR | Interventional Therapeutics Corp. | KNT | Class II | 1993-11-17 |
| K923394 | MENLO CARE AQUASTENT SET | Menlo Care, Inc. | FAD | Class II | 1993-11-16 |
| K932629 | FIBER OPTIC LIGHT CABLE | Stephen Chakoff, Inc. | GCJ | Class II | 1993-11-16 |
| K932631 | XENON LIGHT SOURCE ILLUMINATOR | Stephen Chakoff, Inc. | GCJ | Class II | 1993-11-16 |
| K933400 | KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR | Kendall Healthcare Products Co. Div.Of Tyco Health | KOD | Class II | 1993-11-15 |
| K926016 | NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE | Zinnanti Surgical Instruments, Inc. | GCJ | Class II | 1993-11-12 |
| K933448 | MANAN ADAPTER FOR BIP BIOPSY DEVICE | Manan Medical Products, Inc. | KNW | Class II | 1993-11-12 |
| K933985 | MICROWAVE INSURG INTRODUCER | Boston Scientific Corp | GCJ | Class II | 1993-11-12 |
| K925959 | FORCEPS FOR LAPAROSCOPIC SURGERY GU USE | Zinnanti Surgical Instruments, Inc. | GCJ | Class II | 1993-11-12 |
| K933720 | INSTRUMENT ACTUATING DEVICE (IAD) | Unisurge, Inc. | GCJ | Class II | 1993-11-12 |
| K933868 | ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES | Angiolaz, Inc. | GCT | Class II | 1993-11-10 |
| K932697 | ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR | Innovative Surgical, Inc. | GCJ | Class II | 1993-11-10 |
| K931928 | JARIT SURGICAL INSTRUMENTS | J. Jamner Surgical Instruments, Inc. | GCJ | Class II | 1993-11-10 |
| K925392 | BIOPSY FORCEPS | Endo-Therapeutics, Inc. | FCL | Class I | 1993-11-05 |
| K933110 | OLYMPUS GUIDE WIRE | Olympus Corp. | OCY | Class II | 1993-11-04 |
| K930171 | FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR | Fiberoptic Sensor Technlogies, Inc. | FEN | Class II | 1993-11-04 |
| K934585 | PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL | Lafayette Pharmaceuticals, Inc. | FCD | Class I | 1993-11-03 |
| K932979 | EXTERNAL STABILITY PAD | Louisville Laboratories, Inc. | GCJ | Class II | 1993-11-02 |
| K933456 | COMED TROGARD(TM) BLUNT TIP TROCAR/SLEEVE | Conmedcorp | GCJ | Class II | 1993-11-02 |
| K933421 | ENDOSCOPIC INSTRUMENTS AND ACCESSDORIES | L.A.S.E.R., Inc. | GCJ | Class II | 1993-11-02 |
| K931954 | THORACOSCOPE/LAPAROSCOPE | Surgical Technologies, Inc. | GCM | Class II | 1993-11-02 |
| K933717 | OLYMPUS MEASURING DEVICES | Olympus Corp. | FDS | Class II | 1993-11-02 |
| K933399 | KENDALL URODYNAMIC CATHETERS | Kendall Healthcare Products Co. Div.Of Tyco Health | FEN | Class II | 1993-11-02 |
| K933354 | HOBBS MEDICAL CLEANING BRUSH | Hobbs Medical, Inc. | FEB | Class II | 1993-10-28 |
| K930302 | BIRTCHER SURE CLEAN INSTRUMENT SYSTEM | Birtcher Medical Systems, Inc. | GCI | Class II | 1993-10-27 |
| K932698 | ISI(R) HOOK SUTURES SCISSORS | Innovative Surgical, Inc. | GCJ | Class II | 1993-10-27 |
| K933515 | BOOTY ENDOSCOPE WARMER | T-Med, Inc. | GCI | Class II | 1993-10-27 |
| K926038 | FLEX-TECH BALLOON DILATOR | Cape Tech Medical Products | KNQ | Class II | 1993-10-25 |
| K933388 | BRIMFIELD PRECISION SCISSOR | Springfield Surgical Instruments | GCJ | Class II | 1993-10-21 |
| K933243 | KNOT PUSHER | Advanced Surgical, Inc. | GCJ | Class II | 1993-10-21 |
| K933106 | ENDOSCOPE | Origin Medsystems, Inc. | ODF | Class II | 1993-10-19 |
| K931464 | BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE | Baxter Healthcare Corp | LYK | Class II | 1993-10-18 |
| K933387 | BRIMFIELD PRECISION GRASPER/DISSECTOR | Springfield Surgical Instruments | GCJ | Class II | 1993-10-15 |
| K926480 | LAPAROSCOPIC BALLOON RETRACTOR | Origin Medsystems, Inc. | GCJ | Class II | 1993-10-15 |
| K933909 | SCOPE WASH | Core Dynamics, Inc. | GCJ | Class II | 1993-10-15 |
| K922562 | STIMTECH PFX, CATALOG NUMBER 78-8540 | Stimtech Products | KPI | Class II | 1993-10-13 |
| K932855 | HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE | Hollister, Inc. | KNT | Class II | 1993-10-13 |
| K932648 | QUICK SWITCH LAPAROSCOPIC INSTRUMENTS | Microline Pentax, Inc. | GCJ | Class II | 1993-10-12 |
| K922608 | ENDOPATH EP DISPOSABLE TROCAR | ETHICON, Inc. | GCJ | Class II | 1993-10-12 |
| K930605 | APPLIER, SURGICAL, CLIP | Unisurge, Inc. | GCJ | Class II | 1993-10-08 |
| K924996 | FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE | Abbott Laboratories | KNT | Class II | 1993-10-08 |
| K930135 | SILICONE RECTAL BALLOON | Cook Urological, Inc. | FEN | Class II | 1993-10-08 |
| K932930 | CANDELA MINIBRUSH | Candela Laser Corp. | FEB | Class II | 1993-10-05 |
| K934134 | DISTENTION INSTRUMENT, MODIFICATION | Origin Medsystems, Inc. | GCJ | Class II | 1993-10-05 |
| K931044 | OXY-BLOC | Gi Supply | MNK | Class I | 1993-10-04 |
| K933160 | PROCEDURE KITS | Ethicon Endo-Surgery, Inc. | GCJ | Class II | 1993-10-01 |
| K932885 | AUTO SUTURE ENDOSCOPIC INSTRUMENT CLAMP | United States Surgical, A Division of Tyco Healthc | GCJ | Class II | 1993-09-29 |
| K932408 | AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS | Baxter Healthcare Corp | FFN | Class I | 1993-09-28 |
| K931201 | TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER | Tri-Med Specialties, Inc. | OCX | Class II | 1993-09-28 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.