meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
50
Latest Decision
1990-06-22

Clearances · page 85 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K901441 ALBERT MORTON UROLOGICAL CATHETER Transinternational Marketing Group GBM Class II 1990-06-22
K896932 INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE The Witmoore Group, Inc. FCG Class II 1990-06-22
K901582 DOBBHOFF BILIARY STENT SET Biosearch Medical Products, Inc. FGE Class II 1990-06-22
K896933 INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE GUN The Witmoore Group, Inc. KNW Class II 1990-06-22
K901427 BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON Telemed Systems, Inc. FGE Class II 1990-06-22
K901426 COLONIC BALLOON DILATOR Telemed Systems, Inc. FFP Class I 1990-06-21
K901433 SURE-FLEX ANASTOMOTIC BALLOON DILATOR Telemed Systems, Inc. FGE Class II 1990-06-21
K901425 PYLORIC BALLOON DILATOR Telemed Systems, Inc. FAT Class II 1990-06-21
K901424 ESOPHAGEAL BALLOON DILATOR Telemed Systems, Inc. KNQ Class II 1990-06-21
K901432 BILIARY BALLOON DILATOR Telemed Systems, Inc. FGE Class II 1990-06-21
K901336 ASI HEMOSTASIS CATHETER Advanced Surgical Intervention, Inc. GBM Class II 1990-06-20
K901134 ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE Fresenius Pharma KNT Class II 1990-06-20
K901437 TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE Telemed Systems, Inc. FBK Class II 1990-06-18
K901443 ZIMMON PAPILLOTOME Wilson-Cook Medical, Inc. KNS Class II 1990-06-18
K901431 TELEMED ERCP CANNULA Telemed Systems, Inc. FGE Class II 1990-06-18
K901436 BRONCHIAL CYTOLOGY BRUSH Telemed Systems, Inc. FDX Class II 1990-06-18
K901428 DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE Telemed Systems, Inc. FDI Class II 1990-06-18
K901322 DOBBHOFF(R) POLYPECTOMY SNARE Biosearch Medical Products, Inc. FDI Class II 1990-06-15
K900494 SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM Synectics-Dantec FAP Class II 1990-06-11
K901439 DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN Telemed Systems, Inc. FEB Class II 1990-06-11
K900016 TRANS/R - FP(3) CIVCO Medical Instruments Co., Inc. FCY Class I 1990-06-11
K901501 CORPAK GASTROSTOMY TUBE Corpak Co. KGC Class II 1990-06-11
K901339 BIOPSY FORCEPS (NON-RIGID) Applied Medical Technologies KNW Class II 1990-06-11
K901133 DURACATH Impra, Inc. LFJ Class II 1990-06-08
K900770 HOME URODATA SYSTEM(TM) Biodan Medical Systems, Ltd. EXY Class II 1990-06-08
K902366 MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT Synectics-Dantec FFT Class I 1990-06-08
K891007 NONIMPLANTED ELECTRICAL CONTINENCE DEVICE Tridak Division of Indicon, Inc. KPI Class II 1990-06-07
K901938 SUPER STRENGTH DENTURE ADHESIVE CREAM Teledyne Getz KOB Class II 1990-06-06
K901429 SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE Telemed Systems, Inc. OCY Class II 1990-06-05
K901214 RIGID URETEROSCOPE Applied Urology, Inc. FGB Class II 1990-06-01
K901996 FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR Filtertek, Inc. FIB Class II 1990-06-01
K901844 URESIL TRU-CLOSE DRAINAGE BAG Uresil Corp. EXF Class II 1990-06-01
K901753 600 OR 1200 ML. ENTERAL BAG ADMINISTRATION SET Chartermed, Inc. KNT Class II 1990-06-01
K901130 ENTERA-FLO FEEDING TUBE Fresenius Pharma KNT Class II 1990-06-01
K896713 ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. Advanced Surgical Intervention, Inc. KOE Class II 1990-05-24
K901061 SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000 Akcess Medical Products, Inc. LFJ Class II 1990-05-22
K901010 FLEXIBLE CHOLEDOCHOSCOPE Intramed Laboratories, Inc. FBN Class II 1990-05-22
K901286 AMICON HEMOCONCENTRATOR SET Amicon, Inc. KDI Class II 1990-05-18
K900760 AMS OPTILUME INFLATION SYRINGE American Medical Systems, Inc. KOE Class II 1990-05-17
K900813 BARD SHORT RIGID URETEROSCOPE C.R. Bard, Inc. FGB Class II 1990-05-17
K900761 AMS OPTILUME(TM) PROSTATE BALLOON DILATOR American Medical Systems, Inc. KOE Class II 1990-05-17
K900380 MEDILASE 5010 ENDOSCOPE CONSOLE Medical Laser, Inc. FET Class II 1990-05-15
K900841 HEMODIALYSIS TRANSDUCER PROTECTOR Mediflex Intl. FIB Class II 1990-05-15
K900904 CANDELA DIRECTABLE BILIARY CATHETER SYSTEM Candela Laser Corp. FGE Class II 1990-05-11
K900835 MODIFIED PERM-CATH Quinton, Inc. LFJ Class II 1990-05-09
K896568 DUALYSE-CATH - CODES #1132.212, 1132.112 Vygon Corp. LFJ Class II 1990-05-09
K901228 MULTI-STRIP Bellhouse Medical, Inc. FKX Class II 1990-05-07
K901318 STAYEREC SYSTEM(TM) Osbon Medical Systems, Ltd. LKY Class II 1990-05-04
K900774 DACOMED NEGATIVE PRESSURE ERECTION DEVICE Dacomed Corp. LKY Class II 1990-05-04
K901603 MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER Bivona Medical Technologies KOB Class II 1990-05-04
K901223 VACUUM ERECTION DEVICE (VED) Mission Pharmacal Co. LKY Class II 1990-05-04
K896288 FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM Oakfield Instruments, Ltd. FFT Class I 1990-05-04
K896575 DANTEC MENUET Dantec Medical, Inc. FAP Class II 1990-05-03
K896695 DYNA-FLO URINARY DRAINAGE BAG Medline Industries, Inc. EYZ Class I 1990-05-02
K895366 ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE Fresenius USA, Inc. KNT Class II 1990-05-02
K895696 ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU Delmed, Inc. KNT Class II 1990-05-02
K900852 MAGNET RETRIEVAL CATHETER Cook, Inc. KNT Class II 1990-05-02
K895330 600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA Delmed, Inc. KNT Class II 1990-05-02
K895246 FRENTA(R) DUO-SET Delmed, Inc. KNT Class II 1990-05-02
K895933 ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III Delmed, Inc. KNT Class II 1990-05-02
K900559 RESPONSE EXTERNAL PENILE RIGIDITY DEVICE Smith-Collins Pharmaceutical, Inc. LKY Class II 1990-05-02
K896688 URINE COLLECTOR LEG BAG Medline Industries, Inc. KNX Class II 1990-05-02
K895919 ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III Delmed, Inc. KNT Class II 1990-05-02
K891927 TELEMETRY POWER PACK MODEL 2 Lucas & Rhea Mfg. FCP Class I 1990-04-26
K895538 ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY Trimedyne, Inc. LYK Class II 1990-04-26
K900781 WORKING CHANNEL VALVE Applied Urology, Inc. FFY Class I 1990-04-25
K896357 SAFE AID DEVICE IMPOTENCE DEVICE Dr. John P. March LKY Class II 1990-04-25
K896407 HAEMOTRONIC BLOOD LINE SET Healthcare Suppliers, Inc. FJK Class II 1990-04-25
K894883 PHYCON ALL SILICONE BALLOON CATHETER Vitaid, Ltd. EZL Class II 1990-04-25
K900803 DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S Akcess Medical Products, Inc. LFJ Class II 1990-04-25
K900148 KIT PAK IRRIGATION TRAY Kit Pak, Inc. EYN Class II 1990-04-23
K900305 INTRAVASCULAR IMAGING SYSTEMS Intertherapy, Inc. LYK Class II 1990-04-20
K900306 HEMODIALYSIS BLOOD LINES Gainor Medical Europe, Ltd. KOC Class II 1990-04-20
K901038 SPS 550-IPS (INTEGRATED PATIENT STATION) Baxter Healthcare Corp FIL Class II 1990-04-19
K900737 PISTON IRRIGATION TRAY Orion Life Systems, Inc. EYN Class II 1990-04-19
K900963 GS-4350 TROCAR ONLY, 5.5MM Solos Endoscopy, Inc. FBM Class I 1990-04-18
K900961 GS-4100 REDUCER SLEEVE, 5MM TO 3MM Solos Endoscopy, Inc. FBM Class I 1990-04-18
K900955 GS-4000 REDUCER SLEEVE, 11MM TO 5MM Solos Endoscopy, Inc. FBM Class I 1990-04-18
K900964 CANNULA AND TROCAR, 11MM Solos Endoscopy, Inc. FBM Class I 1990-04-18
K900965 GS-4550 TROCAR ONLY, 11MM Solos Endoscopy, Inc. FBM Class I 1990-04-18
K900962 GS-4300 CANNULA AND TROCAR, 5.5MM Solos Endoscopy, Inc. FBM Class I 1990-04-18
K900736 BULB IRRIGATION TRAY Orion Life Systems, Inc. EYN Class II 1990-04-17
K900229 BARD CONFORMACATH FOLEY CATHETER C.R. Bard, Inc. KOD Class II 1990-04-17
K896129 URINARY LEG BAG Cypress Medical Products, Ltd. FAQ Class I 1990-04-16
K896147 BIOPSY FORCEP (NON-ELECTRIC) Portlyn Corp. FCL Class I 1990-04-16
K900848 ENEMA KIT 'STRAIGHT' DESIGN Custom Medical Products, Ltd. FCE Class I 1990-04-13
K900847 ENEMA KIT 'Y' DESIGN Custom Medical Products, Ltd. FCE Class I 1990-04-13
K896323 WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS Wilson-Cook Medical, Inc. FGE Class II 1990-04-09
K893636 GUARDIAN FORCEP Endo-Scientific, Inc. FCL Class I 1990-04-09
K896318 WILSON-COOK CYTOLOGY BRUSHES Wilson-Cook Medical, Inc. FDX Class II 1990-04-09
K900123 AUTO SUTURE SURGIPORT SPIRAL SLEEVE United States Surgical, A Division of Tyco Healthc FBQ Class II 1990-04-04
K896391 BARD/ANGIOMED STENTS C.R. Bard, Inc. FGE Class II 1990-03-29
K897181 L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE Intl. Medical Marketing, Inc. FPD Class II 1990-03-27
K897153 CVIS INSIGHT IMAGING CATHETER Cardiovascular Imaging Systems, Inc. LYK Class II 1990-03-26
K901000 URO TEX URINALS Sierra Laboratories, Inc. EYZ Class I 1990-03-26
K895992 CATHETER EXTENSION SET CAT. NO. 48-3027-9 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-23
K895792 DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-23
K900226 DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-22
K900142 DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-22
K896205 MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE Dexide, Inc. GCI Class II 1990-03-22

11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.