Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 55
- Latest Decision
- 1992-11-20
Clearances · page 78 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K922751 | ORIGIN FLEXIBLE PORT | Origin Medsystems, Inc. | GCJ | Class II | 1992-11-20 |
| K914397 | OXFORD OPTRONIX MPM 3S | Dia-Stron, Ltd. | FTI | Class II | 1992-11-16 |
| K924103 | CLEANING BRUSH | United States Endoscopy Group, Inc. | FEB | Class II | 1992-11-16 |
| K911349 | E-Z-EM ENTEROCLYSIS CATHETER SET | E-Z-Em, Inc. | EZK | Class II | 1992-11-16 |
| K915725 | CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE | Clarus Medical Systems, Inc. | FHO | Class II | 1992-11-16 |
| K915317 | PUTMAN STABILIZER | J. Michael Putman, M.D., P.A. | GCJ | Class II | 1992-11-06 |
| K921336 | TROCAR GRASPER/ANVIL APPROXIMATOR | Endoscopic Surgical Products, Inc. | GCJ | Class II | 1992-11-06 |
| K922086 | BARD BIOPSY FORCEPS | C.R. Bard, Inc. | GCL | Class II | 1992-10-30 |
| K924406 | CONVEEN(R) LEG BAG(500 ML) | Coloplast A/S | FAQ | Class I | 1992-10-30 |
| K922209 | NASOGRASTRIC TUBBE HOLDER | Innovative Medical Design Corp. | KNT | Class II | 1992-10-30 |
| K920551 | 120 FR OPTILUME PROSTATE BALLOON DILATOR | American Medical Systems, Inc. | KOE | Class II | 1992-10-28 |
| K921451 | EVACUATOR, GASTRO-UROLOGY | Northgate Technologies, Inc. | KQT | Class II | 1992-10-28 |
| K921839 | ENTRAC URETERAL BALLOON DILATION CATHETERS | American Medical Systems, Inc. | EZN | Class II | 1992-10-28 |
| K921088 | EVACUATOR, GASTRO-UROLOGY | Northgate Technologies, Inc. | KQT | Class II | 1992-10-28 |
| K921690 | FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE SYSTEM | Vision-Sciences, Inc. | FAM | Class II | 1992-10-28 |
| K921104 | LOPEZ VALVE WITH NG SUMP TUBE | Icu Medical, Inc. | FEG | Class II | 1992-10-26 |
| K924451 | INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR | Interventional Therapeutics Corp. | FGE | Class II | 1992-10-23 |
| K924027 | DISLODGER, STONE, BASKET, URETERAL, METAL | Annex Medical, Inc. | FFL | Class II | 1992-10-20 |
| K924086 | NICKI, MODEL NUMBER USD-NK-UP1 | Laborie Medical Technologies, Ltd. | FAP | Class II | 1992-10-20 |
| K923671 | COX DISPOSABLE POLYPECTOMY SNARES | Cox Medical Ent., Inc. | FDI | Class II | 1992-10-13 |
| K922161 | GRICE SOFT TISSUE BIOPSY KIT | Ideal Medical, Inc. | KNW | Class II | 1992-10-13 |
| K915790 | ENDO-GARD ELECTROSURGICAL TROCAR | Conmedcorp | GCJ | Class II | 1992-10-09 |
| K923545 | BARD 7 FR. FIBER OPTIC ASSEMBLY | C.R. Bard, Inc. | FGB | Class II | 1992-10-08 |
| K921304 | DDV LIGATOR | North American Medical, Inc. | KOA | Class I | 1992-10-05 |
| K923210 | SYSTEM 3000 XENON VIDEOLAP LIGHT | Cabot Medical Corp. | GCT | Class II | 1992-10-05 |
| K923607 | RADIFOCUS GUIDE WIRE M | Terumo Medical Corp. | KOD | Class II | 1992-10-02 |
| K924407 | CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH | Coloplast A/S | EXJ | Class I | 1992-09-23 |
| K920695 | URETERAL STENT | Applied Urology, Inc. | FAD | Class II | 1992-09-23 |
| K922971 | NO-SCALPEL VASCETOMY INSTRUMENTS | Pilling Co. | KOA | Class I | 1992-09-23 |
| K923672 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH | Cox Medical Ent., Inc. | FEB | Class II | 1992-09-23 |
| K923489 | COX DISPOSABLE RETRIEVAL DEVICES | Cox Medical Ent., Inc. | OCZ | Class II | 1992-09-23 |
| K921054 | KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH. | Kendall Healthcare Products Co. Div.Of Tyco Health | KOD | Class II | 1992-09-23 |
| K923687 | ONE DIRECTIONAL CLEANING BRUSH | Endoscopy Support Services, Inc. | FEB | Class II | 1992-09-23 |
| K920029 | DEXTROLYTE II CAPD TRNSFER SET | National Medical Care, Medical Products Div., Inc. | KDJ | Class II | 1992-09-21 |
| K920697 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP | National Medical Care, Medical Products Div., Inc. | FJH | Class II | 1992-09-21 |
| K920586 | DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET | National Medical Care, Medical Products Div., Inc. | KDJ | Class II | 1992-09-21 |
| K920693 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 | National Medical Care, Medical Products Div., Inc. | FJG | Class II | 1992-09-21 |
| K920797 | HEMODIALYSIS BLOOD TUBING SET | National Medical Care, Medical Products Div., Inc. | FJK | Class II | 1992-09-21 |
| K920068 | AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR | United States Surgical, A Division of Tyco Healthc | GCJ | Class II | 1992-09-17 |
| K920451 | ENDOTEK ULTRA SYSTEM | Surgitek | FAP | Class II | 1992-09-17 |
| K921228 | BENDEREV PROTECT-A-PASS NEEDLE | Eimark Labs, Inc. | KOA | Class I | 1992-09-14 |
| K921200 | GUIDEWIRE | Lake Region Mfg., Inc. | KNY | Class II | 1992-09-04 |
| K920619 | TRI-MED GASTRIC LAVAGE SYSTEM | Tri-Med Specialties, Inc. | KDH | Class II | 1992-09-04 |
| K920527 | TRI-MED QUICK-STEP GASTRIC LAVAGE KIT | Tri-Med Specialties, Inc. | KDH | Class II | 1992-09-04 |
| K921415 | IRRIGATION TUBING SET | Psi Medical Products, Inc. | KOD | Class II | 1992-09-04 |
| K920777 | LABORIE URODYNAMICS PROCESSOR | R. Laborie Surgical , Ltd. | FAP | Class II | 1992-09-04 |
| K921024 | URO-TOTE LEG BAG | Neotech Products, Inc. | KNX | Class II | 1992-09-02 |
| K922526 | DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL DEVICES | Davol, Inc. | GCJ | Class II | 1992-09-02 |
| K922246 | TUBING SET W/ IRRIGATION & ASPIRATION VALVING | Everest Medical Corp. | GCJ | Class II | 1992-09-02 |
| K922879 | MEADOX SURGIMED BIOPSY GUN III | Meadox Medicals, Div. Boston Scientific Corp. | KNW | Class II | 1992-09-01 |
| K920342 | BARD STONE REMOVAL BALLOON CATHETER | C.R. Bard, Inc. | GCA | Class II | 1992-08-26 |
| K920762 | BIOSPSY FORCEPS | Symbiosis Corp. | OCZ | Class II | 1992-08-26 |
| K921697 | FLEXIFLO COMPANION ENTERAL PUMP SETS AND CONTAINER | Abbott Laboratories | KNT | Class II | 1992-08-25 |
| K922678 | LOOP RETRIEVER | Annex Medical, Inc. | FFL | Class II | 1992-08-25 |
| K922851 | CYTOLOGY BRUSH | Annex Medical, Inc. | FDX | Class II | 1992-08-25 |
| K920224 | DOSCOPE AND ACESSORIES | Applied Laparoscopy | FBN | Class II | 1992-08-21 |
| K922542 | GRASPING FORCEPS | Surgitek | FGO | Class II | 1992-08-19 |
| K922346 | FEMALE URINE SAMPLING DEVICE | Mentor Corp. | FCN | Class II | 1992-08-14 |
| K922405 | O.R.C. ADAPTER | O.R. Concepts, Inc. | GCJ | Class II | 1992-08-14 |
| K922349 | DOWD(TM) II | Boston Scientific Corp | KOE | Class II | 1992-08-14 |
| K922571 | INSTRUMENT, MANUAL, GENERAL SURGICAL | Symbiosis Corp. | GCJ | Class II | 1992-08-11 |
| K922192 | VAS DILATOR | Cook Urological, Inc. | KOA | Class I | 1992-08-07 |
| K921253 | INSTRUMENT IRRIGATION PUMP | Psi Medical Products, Inc. | KOD | Class II | 1992-08-06 |
| K921120 | FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER | Cook Urological, Inc. | FED | Class II | 1992-08-04 |
| K922082 | LAPAROSCOPIC INTRODUCER | Endomedix | GCJ | Class II | 1992-08-03 |
| K922114 | ENDOSCOPIC RETRIEVAL BASKET | Intramed Laboratories, Inc. | FFL | Class II | 1992-08-03 |
| K921062 | GAELTEC MPR SERIES | Medical Measurements, Inc. | FFX | Class II | 1992-07-30 |
| K921006 | LAPAROSCOPIC RETRACTOR SYSTEM | Laparomed Corp. | GCS | Class II | 1992-07-28 |
| K920026 | NOBLES-LAI IMAGING SYSTEM | Nobles-Lai Engineering, Inc. | FET | Class II | 1992-07-28 |
| K921390 | XENON LIGHT SOURCE AND ACCESSORIES | Coopervision Surgical | GCT | Class II | 1992-07-27 |
| K920614 | HEMO-BAND | Innovations IN Access, Inc. | KOC | Class II | 1992-07-27 |
| K915219 | URETHRAL ELECTRODE SHEATH | Applied Urology, Inc. | FAS | Class II | 1992-07-23 |
| K920575 | MERKUR 4000 | F.M. Wiest USA, Inc. | FAP | Class II | 1992-07-23 |
| K921431 | POTTY PAGER | Ideas For Living | KPN | Class II | 1992-07-21 |
| K920599 | HOOK SURGICAL INSTRUMENT | Origin Medsystems, Inc. | GCJ | Class II | 1992-07-15 |
| K922243 | E-Z CLAMP#1 AND#2 | Southwest Medical Mfg., Inc. | GCJ | Class II | 1992-07-14 |
| K921709 | ENDOBAG, MODIFICATION | Dexide, Inc. | GCJ | Class II | 1992-07-14 |
| K922655 | SUCTION/IRRIGATION Y TUBING SET | Core Dynamics, Inc. | GCJ | Class II | 1992-07-14 |
| K921260 | LAPAROSCOPIC SURGICAL INSTRUMETNS | Jana Medical | GCJ | Class II | 1992-07-13 |
| K911577 | HYPOTRANS MODEL 750 | Martin Mclane Medical | KDK | Class II | 1992-07-08 |
| K921922 | GRICE LAPAROSCOPIC SUTURING NEEDLE | Ideal Medical, Inc. | GCJ | Class II | 1992-07-08 |
| K914692 | URINARY DIVERSION EVACUATING CATHETER | Cook Urological, Inc. | EXD | Class II | 1992-07-02 |
| K921654 | MCLEAN-STOCK PERCUTANEOUS T-TUBE SET | Cook, Inc. | FGE | Class II | 1992-07-02 |
| K920946 | UROLOGICAL BALLOON DILATATION CATHETER | Boston Scientific Corp | EZN | Class II | 1992-07-01 |
| K915593 | TRANSDUCER PROTECTOR | United Pharmaceutical and Medical Supply Co. | FIB | Class II | 1992-07-01 |
| K914517 | SD-200IEHL(TM) | Northgate Technologies, Inc. | FFK | Class II | 1992-06-30 |
| K915735 | FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT | Abbott Laboratories | KNT | Class II | 1992-06-24 |
| K914459 | AUTOMATIC TUBING CLAMP | Rocky Mountain Research, Inc. | FIG | Class II | 1992-06-24 |
| K920423 | OLYMPIC SMART SCALE CARE CENTER | Olympic Medical Corp. | FEW | Class II | 1992-06-11 |
| K914752 | AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS | United States Surgical, A Division of Tyco Healthc | GCJ | Class II | 1992-06-11 |
| K913817 | MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION | Synectics-Dantec | FFT | Class I | 1992-06-11 |
| K922401 | 4 SURE TM COLOSTOMY POUCH | Boston Pacific Medical, Inc. | EZQ | Class I | 1992-06-10 |
| K914300 | PHOENIX 5 URODYNAMICS SYSTEM | Aspen Medical , Ltd. | FAP | Class II | 1992-06-02 |
| K921191 | GIANTURCO-ROSCH BILIARY Z STENT | Cook, Inc. | FGE | Class II | 1992-05-15 |
| K921055 | KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER | Kendall Healthcare Products Co. Div.Of Tyco Health | KNY | Class II | 1992-05-11 |
| K920409 | DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE | Dacomed Corp. | LKY | Class II | 1992-05-11 |
| K914887 | ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT | Mallinckrodt Medical | FRQ | Class II | 1992-05-08 |
| K920236 | CHOLANGIOGRAM CATHETER KIT | Mccol Medical,Inc. | FGE | Class II | 1992-05-06 |
| K921029 | DOBBHOFF BIPOLAR ADAPTER | Biosearch Medical Products, Inc. | KNS | Class II | 1992-05-06 |
| K920711 | ENTRAC URETHRAL BALLOON DILATATION CATHETER | American Medical Systems, Inc. | KOE | Class II | 1992-05-06 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.