Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 44
- Latest Decision
- 1993-04-07
Clearances · page 77 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K924035 | ENDOPATH II DISPOSABLE SURGICAL TROCAR & SLEEVE | Ethicon Endo-Surgery, Inc. | GCJ | Class II | 1993-04-07 |
| K930567 | MODIFIED ENDOSCOPIC CLAMP | United States Surgical, A Division of Tyco Healthc | GCJ | Class II | 1993-04-07 |
| K926079 | DMI LAPAROSCOPIC ELECTRODES | Diversified Medical Instruments, Inc. | GCJ | Class II | 1993-04-07 |
| K923818 | O.R. CONCEPTS' IRRIGATING KITTNER | O.R. Concepts, Inc. | FGS | Class II | 1993-04-07 |
| K923983 | PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT | Sandoz Nutrition | KNT | Class II | 1993-04-06 |
| K923726 | KENSEY NASH DYNAMIC CLIP SYSTEM | Kensey Nash Corp. | GCJ | Class II | 1993-04-06 |
| K920595 | ENDOPATH INTERCEED ABSORBABLE ADHESION BARRIER | ETHICON, Inc. | GCJ | Class II | 1993-04-05 |
| K922685 | TROCARS | Endoscopic Technologies, Inc. | GCJ | Class II | 1993-04-05 |
| K926104 | POLYP NET | United States Endoscopy Group, Inc. | GCJ | Class II | 1993-04-05 |
| K924058 | TROCAR | Endo Technic Corp. | GCJ | Class II | 1993-03-30 |
| K922797 | AESCULAP TROCAR INSTRUMENT SET | Aesculap, Inc. | GCJ | Class II | 1993-03-30 |
| K921179 | OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 | Keymed, Inc. | FEB | Class II | 1993-03-29 |
| K925361 | BIOPSY FORCEPS, ELECTRIC | United States Endoscopy Group, Inc. | KGE | Class II | 1993-03-29 |
| K922431 | BARD LATEX URINARY CATHETERS | C.R. Bard, Inc. | KOD | Class II | 1993-03-25 |
| K926423 | S/2(TM) STOPCOCK | Psi Medical Products, Inc. | FGB | Class II | 1993-03-23 |
| K926433 | 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 | Baxter Edwards | LYK | Class II | 1993-03-23 |
| K915837 | NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEM | C.R. Bard, Inc. | KNT | Class II | 1993-03-23 |
| K920979 | CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) | Codman & Shurtleff, Inc. | GCQ | Class II | 1993-03-23 |
| K926559 | PROACT BIOPSY NEEDLE ENCHANCEMENTS | Proact, Ltd. | FCG | Class II | 1993-03-22 |
| K924022 | O.R. CONCEPTS SECONDARY CANNULA | O.R. Concepts, Inc. | GCJ | Class II | 1993-03-18 |
| K922094 | DISSECTION INSTRUMENT | Origin Medsystems, Inc. | GCJ | Class II | 1993-03-18 |
| K924764 | OVERTUBE FOR ENDSCOPIC LIGATOR | Superior Healthcare Group, Inc. | MNK | Class I | 1993-03-15 |
| K930082 | ENDOSCOPE AND ACCESSORIES | Weck Endoscopy | GCJ | Class II | 1993-03-15 |
| K923982 | OLYMPUS OES LAPAROSCOPY SYSTEM | Olympus Corp. | GCJ | Class II | 1993-03-15 |
| K915308 | PEG GASTROSTOMY TUBE KIT | Sandoz Nutrition | FPD | Class II | 1993-03-12 |
| K926282 | MCKERNAN-POTTS GRASPING FORCEPS | Aslan Medical Technologies, Ltd. | GCJ | Class II | 1993-03-09 |
| K926281 | MCKERNAN-ADSON AGGRESSIVE FORCEPS | Aslan Medical Technologies, Ltd. | GCJ | Class II | 1993-03-09 |
| K923436 | ILLUMINATED URETERAL CATHETER | Cook Urological, Inc. | FCS | Class II | 1993-03-05 |
| K926344 | HYDROPHILIC COATED GUIDEWIRE | Surgitek | KNY | Class II | 1993-03-05 |
| K914790 | HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R | National Medical Care, Medical Products Div., Inc. | FJI | Class II | 1993-03-05 |
| K921287 | SURGICAL RETRACTOR | Advanced Surgical, Inc. | GCJ | Class II | 1993-03-04 |
| K930005 | DRITRAINER | Laborie Medical Technologies, Ltd. | KPN | Class II | 1993-03-03 |
| K923820 | LAPAROSCOPIC SURGICAL INSTRUMENTS | Microcut, Inc. | GCJ | Class II | 1993-03-03 |
| K915174 | JMS APHERESIS NEEDLE | Jms Co., Ltd. | FIE | Class II | 1993-03-02 |
| K925824 | SOLOS FAN RETRACTORS | Birtcher Medical Systems, Inc. | GCJ | Class II | 1993-03-01 |
| K924228 | OMEGASCOPE | Omega Universal Technologies, Ltd. | FBN | Class II | 1993-02-26 |
| K921838 | ACUCISE URETERAL CUTTING CATHETER | Applied Urology, Inc. | EYB | Class II | 1993-02-26 |
| K921052 | FRESENIUS VARIABLE FILL MONITOR | Fresenius USA, Inc. | KDJ | Class II | 1993-02-25 |
| K911617 | UROTECH CATHETER | Urotech U.S.A., Inc. | EZL | Class II | 1993-02-25 |
| K924554 | CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE | Clarus Medical Systems, Inc. | LYK | Class II | 1993-02-25 |
| K925565 | MAGNETIC RETRIEVER | Cook Urological, Inc. | GCJ | Class II | 1993-02-23 |
| K925410 | SYMBIOSIS HEMOSTATIC WAND | Symbiosis Corp. | GCJ | Class II | 1993-02-23 |
| K925669 | DEVMED LENS WASH SHEATH | Devmed Corp. | GCJ | Class II | 1993-02-23 |
| K922826 | FLEXIBLE FIBER OPTIC ENDOSCOPE | Optimed Technologies, Inc. | FGA | Class II | 1993-02-19 |
| K920574 | CAMSYS 6300 | F.M. Wiest USA, Inc. | EXQ | Class II | 1993-02-17 |
| K922939 | BARD MONOPTY DISPOSABLE CORE BIOPSY ISNT. W/ CENT. | C.R. Bard, Inc. | KNW | Class II | 1993-02-16 |
| K925918 | PRESSURE TURING AND ACCESSORIES | Applied Medical Resources | GCM | Class II | 1993-02-12 |
| K925198 | KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR | Pilling Co. | GCJ | Class II | 1993-02-12 |
| K923547 | MINIVASIVE LAPAROSCOPY INSTRUMENTS | Minvasive Devices, Inc. | GCJ | Class II | 1993-02-10 |
| K924284 | MICROSURGE DIRECTOR ARTICULATING INSTRUMENTS | Micromec Surgical, Inc. | GCJ | Class II | 1993-02-10 |
| K926004 | ENDOSCOPE AND ACCOSSORIES | Endomedix | FGB | Class II | 1993-02-10 |
| K925267 | GRASPING FORCEPS OR RETRIEVAL FORCEPS | Annex Medical, Inc. | GCJ | Class II | 1993-02-10 |
| K921800 | COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 | Mill-Rose Laboratory | FBK | Class II | 1993-02-08 |
| K925879 | MICROVASIVE INSURG FLAT WIRE BASKETS | Boston Scientific Corp | LQR | Class II | 1993-02-08 |
| K923945 | PLEATMAN SAC SPECIMEN CONTAINER | Cabot Medical Corp. | GCJ | Class II | 1993-02-05 |
| K923464 | URODYNAMIC CATHETERS | R.L. Medical Corp. | FAP | Class II | 1993-02-05 |
| K915423 | HEMO-CATH SILICONE ACCESS CATHETER | Medical Components, Inc. | LFJ | Class II | 1993-02-02 |
| K922123 | AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH | United States Surgical, A Division of Tyco Healthc | GCI | Class II | 1993-02-01 |
| K923822 | AUTOLITH-IEHL | Northgate Technologies, Inc. | FFK | Class II | 1993-01-28 |
| K920671 | DIGI -FLOW | D and D Technology, Inc. | KOC | Class II | 1993-01-28 |
| K924149 | ENDO I/A PROBE | Snowden-Pencer | GCJ | Class II | 1993-01-26 |
| K925149 | AUTO SUTURE ENDOSCOPIC KNOT PUSHER | United States Surgical, A Division of Tyco Healthc | GCJ | Class II | 1993-01-26 |
| K924048 | CABOT DISPOSABLE 10MM SUCTION DEVICE | Cabot Medical Corp. | GCJ | Class II | 1993-01-22 |
| K914934 | HAND PACK | Westmark Hospital Supplies | KDO | Class II | 1993-01-21 |
| K921291 | INMAN MEDICAL PACKING STRIP | Inman Medical Corp. | FER | Class II | 1993-01-21 |
| K920810 | NEO-STAT DIALYSATE METER | Automata Medical Instrumentation, Inc. | FIZ | Class II | 1993-01-15 |
| K923996 | DISPOSABLE VASCULAR ANGIOSCOPE | Endovascular, Inc. | LYK | Class II | 1993-01-13 |
| K925282 | UROLOGICAL CATHETER AND ACCESSORIES | Applied Urology, Inc. | FAD | Class II | 1993-01-13 |
| K922320 | OMNI CYSTOSCOPE | Expanded Optics, Inc. | FAJ | Class II | 1993-01-13 |
| K923528 | INLET IRRIGATION/ASPIRATION VALVE AND PROBES | Inlet Medical, Inc. | GCJ | Class II | 1993-01-12 |
| K923474 | LOW PROFILE GASTROMSTOMY DEVICE | Biosearch Medical Products, Inc. | KNT | Class II | 1993-01-05 |
| K920493 | PEG PREP TRAY | Sandoz Nutrition | KNT | Class II | 1993-01-04 |
| K921127 | PANDA NEEDLE CATHETER JEJUNOSTOMY KIT | Knight Medical, Inc. | KNT | Class II | 1993-01-04 |
| K924107 | ERCP CANNULA | United States Endoscopy Group, Inc. | FGE | Class II | 1992-12-30 |
| K924728 | KNOT PUSHER | Advanced Surgical, Inc. | GCJ | Class II | 1992-12-29 |
| K921040 | ENDOSCOPE | Origin Medsystems, Inc. | GCJ | Class II | 1992-12-24 |
| K922435 | LAPAROSCOPIC CURVED TRIANGLE RETRACTOR | Advanced Surgical, Inc. | GCJ | Class II | 1992-12-24 |
| K925495 | MICROVASIVE INSURG HELICAL & MINI-HELICAL BASKETS | Boston Scientific Corp | LQR | Class II | 1992-12-23 |
| K926040 | HELI-TECH RETRIEVAL BASKET | Cape Tech Medical Products | LQR | Class II | 1992-12-23 |
| K925559 | BILIARY STONE DISLODGER | Annex Medical, Inc. | LQR | Class II | 1992-12-17 |
| K926035 | BARD LEG BAG HOLDER | C.R. Bard, Inc. | FAQ | Class I | 1992-12-17 |
| K924592 | DAVOL KNOT PUSHER | Davol, Inc. | GCJ | Class II | 1992-12-17 |
| K924655 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) | Cox Medical Ent., Inc. | FEB | Class II | 1992-12-15 |
| K923219 | URESIL SPECIMEN RETRIEVAL BAG | Uresil Corp. | GCJ | Class II | 1992-12-15 |
| K922396 | FUJINON FORCEPS -- MODIFICATION | Hobbs Medical, Inc. | FCL | Class I | 1992-12-10 |
| K923200 | AMCATH DISPOSABLE CYTOLOGY BRUSH | Intl. Medical, Inc. | FDX | Class II | 1992-12-07 |
| K920235 | ULTRASOUND GENERATOR MODLE 2270 | Richard Wolf Medical Instruments Corp. | FEO | Class II | 1992-12-07 |
| K923136 | MALE EXTERNAL CATHETER | Rochester Medical Corp. | EXJ | Class I | 1992-12-03 |
| K924102 | NEEDLE | United States Endoscopy Group, Inc. | FBK | Class II | 1992-11-25 |
| K922424 | ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM. | Access Surgical Intl., Inc. | GCJ | Class II | 1992-11-25 |
| K925041 | MCKERNAN ATRAUMATIC FORCEPS | Aslan Medical Technologies, Ltd. | GCJ | Class II | 1992-11-25 |
| K924105 | SNARE FLEXIBLE | United States Endoscopy Group, Inc. | FDI | Class II | 1992-11-24 |
| K924106 | BIOPSY FORCEPS | United States Endoscopy Group, Inc. | KNW | Class II | 1992-11-24 |
| K920361 | BARD BILIARY BALLOON DILATORS | C.R. Bard, Inc. | FGE | Class II | 1992-11-24 |
| K924104 | CYTOLOGY BRUSH | United States Endoscopy Group, Inc. | FDX | Class II | 1992-11-24 |
| K922821 | YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES | Yellow Springs Instrument Co., Inc. | EZL | Class II | 1992-11-23 |
| K921883 | ENDOSCOPE | Optimed Technologies, Inc. | GCM | Class II | 1992-11-23 |
| K921561 | YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES | Ysis, Inc. | EZL | Class II | 1992-11-23 |
| K923055 | OPERATING SCISSORS FOR LAPAROSCOPIC SURGERIES | Numed Technologies, Inc. | GCJ | Class II | 1992-11-23 |
| K924271 | CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLES | Core Medical, Inc. | FCG | Class II | 1992-11-23 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.