meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
32
Latest Decision
1984-05-02

Clearances · page 100 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K840568 ACTIVE LIFE ONE-PIECE CLOSED-END POUCH Convatec, A Division of E.R. Squibb & Sons EXB Class I 1984-05-02
K840917 URINARY MONITORING SYS 240 Vital Metrics, Inc. KNX Class II 1984-05-01
K841014 WEIGHTED FEEDING TUBE W/PRE-INSERTED Ethox Corp. KNT Class II 1984-05-01
K840197 SINGLE LUMEN SUBCLAVIAN CANNULA Shiley, Inc. LFJ Class II 1984-04-25
K831404 BLOOD MONITOR BMM 10-4 Gambro, Inc. LLB Class II 1984-04-25
K840322 HEMOFILTRATION CATHETER HF-100 Vas-Cath of Canada , Ltd. FIQ Class II 1984-04-24
K840680 CENTRY 2000 DIALYSIS CONTROL UNIT Cobe Laboratories, Inc. KDI Class II 1984-04-20
K834576 REAL FIBER OPTIC URETERAL TRANSILLUMIN Douglas Manufacturer Co. FFS Class II 1984-04-20
K834468 DRAINAGE STENT Microvasive FGE Class II 1984-04-20
K841124 DIALYSIS TRAY Medcare Products KOC Class II 1984-04-20
K834395 CHEMLYTE Diachem Laboratories FKQ Class II 1984-04-20
K840415 HEMOCATH Quinton, Inc. FIQ Class II 1984-04-20
K841119 TOPS DISPOS. INFUSION SET/HEMODIALYSIS Top Surgical Manufacturers Co. KNZ Class II 1984-04-20
K840839 MMG FOLEY CATHETER Medical Technologies of Georgia KOD Class II 1984-04-17
K840755 MINIGARD DISPOSABLE LINERS Ipco Corp. EYQ Class I 1984-04-13
K840746 URETERAL DILATOR American Edwards Laboratories KOE Class II 1984-04-13
K834587 HEMODIAL CONCENTRATE Moana Productions, Inc. FKQ Class II 1984-04-13
K840753 AMBEZE DISPOSABLE INCONTINENCE PANTS Ipco Corp. EYQ Class I 1984-04-13
K841033 MILLER-ABBOTT TUBE Inmed Corp. KNT Class II 1984-04-13
K840818 BIOPSY FORCEPS American Endoscopy, Inc. FCL Class I 1984-04-13
K841034 DEAVER T-DRAIN & CATTEL T-DRAIN Inmed Corp. KNT Class II 1984-04-13
K841035 ULTRA BAKER JEJUNOSTOMY TUBE Inmed Corp. KNT Class II 1984-04-13
K840605 LABORIE FIBREOPTIC LIGHT CABLE Tridak Division of Indicon, Inc. FFS Class II 1984-04-13
K841036 RECTAL BALLOON CATHETERS Inmed Corp. KNT Class II 1984-04-13
K841038 BLAKEMORE TUBE Inmed Corp. KNT Class II 1984-04-13
K840754 MAXISHIELD INCONTINENCE CARE SYSTEM Ipco Corp. EYQ Class I 1984-04-13
K841039 CANTOR TUBE Inmed Corp. KNT Class II 1984-04-13
K840284 MULTIPLE SYS-URINE DRAINAGE-CLOSED Luth Corp. KNX Class II 1984-04-13
K840283 MULTIPLE BAG, LEG Luth Corp. KNX Class II 1984-04-13
K834574 USCI ENDOPROSTHESIS C.R. Bard, Inc. FGE Class II 1984-04-05
K840268 IRRIGATION SYSTEM Coloplast A/S EXD Class II 1984-04-05
K840916 DIETO CONTAINER FOR ENTERNAL NUTRIT Gil-Med Industries C/O Kegan & Kegan, Ltd. KNT Class II 1984-04-04
K840656 ENTERNAL Y EXTENSION SET RECORDER Corpak Medsystems KNT Class II 1984-04-04
K834171 OP-CON SURG. INSTRUMENT #3 Imm Enterprises , Ltd. KOA Class I 1984-04-04
K841029 BANGORT LIFESTYLE COLOSTOMY POUCHES Howmedica Corp. EXB Class I 1984-04-04
K833782 SURGITEK ALL SILICONE INFECTION DOUBJ Surgitek FAD Class II 1984-04-02
K840267 FILTRODER FILTERS Coloplast A/S EXB Class I 1984-04-02
K840811 BIOSPAL 3000S Hospal Medical Corp. FKQ Class II 1984-04-02
K834347 FLEXI-FLATE PENILE IMPLANT Surgitek FAE Class II 1984-04-02
K840814 HOSPAL MODEL H1210 Hospal Medical Corp. FKQ Class II 1984-04-02
K840813 BIOSPAL 1200S Hospal Medical Corp. FKQ Class II 1984-04-02
K840812 BIOSPAL 2400S Hospal Medical Corp. FKQ Class II 1984-04-02
K834358 PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA Vas-Cath of Canada , Ltd. FIQ Class II 1984-04-02
K840269 MC 2000 OSTOMY POUCHES Coloplast A/S EXB Class I 1984-04-02
K840265 MC 2002 OSTOMY POUCHES & SKIN FLANGES Coloplast A/S EXB Class I 1984-04-02
K834311 NIGHT TRAINER Maddak, Inc. KPN Class II 1984-03-30
K834447 ECHO MM1000 Mesa Medical, Inc. LIF Class II 1984-03-23
K840543 BLOOD CONCENTRATOR 140 Gambro, Inc. KDI Class II 1984-03-23
K840449 AMICON DIAFILTER 40. HEMOFILTER Medical Device Consultants, Inc. KDI Class II 1984-03-23
K840800 POLYP-SAVER SLEVE Jayco Pharmaceuticals OCZ Class II 1984-03-23
K840702 SECURE W/25MM DIAM. SHEATH & ADHESIVE Warne Surgical Products, Ltd. KNX Class II 1984-03-22
K834192 JAKOBI SURG. INSTRUMENTS #3 21/22/24 Imm Enterprises , Ltd. KOA Class I 1984-03-22
K840679 SERENITY CONTOURED ABSORBENT SHIELDS Johnson & Johnson Consumer Products, Inc. EYQ Class I 1984-03-22
K840703 SECURE W/30MM DIAM, SHEATH & ADHESIVE Warne Surgical Products, Ltd. KNX Class II 1984-03-22
K840062 BSM 2000 DIALYSIS MACHINE Organon Teknika Corp. KOC Class II 1984-03-22
K834401 URETERAL DOUBLE PIGTAIL STENT Hobbs Medical, Inc. FAD Class II 1984-03-22
K840936 NEEDLE CATHETER JEJUNOSTOMY REPAIR KIT Biosearch Medical Products, Inc. KNT Class II 1984-03-22
K834191 JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 Imm Enterprises , Ltd. KOA Class I 1984-03-22
K840704 SECURE W/35MM DIAM, SHEATH/ADHESIVE Warne Surgical Products, Ltd. KNX Class II 1984-03-22
K834351 BILIARY INDWELLING STENT Hobbs Medical, Inc. FGE Class II 1984-03-22
K841003 PROBES, VARIOUS Premier Dental Products Co. KOA Class I 1984-03-20
K840292 URETHRAL CATH. TRAY W/BAG Corpak Co. KNX Class II 1984-03-16
K840157 MILLEREISEN CURVED BIOPSY NEEDLE Preventive Medicine Institute FCG Class II 1984-03-12
K840168 WESTERMAN-JENSEN BIOPSY NEEDLE Popper & Sons, Inc. FCG Class II 1984-03-12
K840354 MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE Sherwood Medical Co. FCG Class II 1984-03-12
K834249 MONOJECT SOFT TISSUE BIOPSY NEEDLE Sherwood Medical Co. FCG Class II 1984-03-12
K832363 FOLEY CATHETERIZATION TRAY-VARIOUS Inmed Corp. KOD Class II 1984-03-07
K840424 HEMOCATH REPAIR KIT Quinton, Inc. KNZ Class II 1984-03-05
K834359 ABSORBENT INCONTINENT PADS & BRIEFS Weyerhaeuser Co. EYQ Class I 1984-03-05
K833687 DISPOS. ENTERIC FEEDING TUBES W/SAFE-T Superior Plastic Products Corp. KNT Class II 1984-03-02
K834512 SANDMILL RMS Sandhill Scientific, Inc. FFT Class I 1984-02-21
K840224 EXTENDED LIFE CAPD SOLUTION TRANSFER Travenol Laboratories, S.A. FKX Class II 1984-02-21
K840436 HEMASITE/RENALOY -VASCULAR ACCESS SHUNT Renal Systems, Inc. FIQ Class II 1984-02-21
K834503 PROFILE URODYNAMIC MONITORING SYS Browne Medical, Inc. FAP Class II 1984-02-21
K834538 LAS-2 ALIGNMENT SYSTEM Therados, Inc. KPO Class II 1984-02-21
K840437 HEMASITE ACCESSORIES MODIFICATION Renal Systems, Inc. KNZ Class II 1984-02-21
K840482 MALE INSERT SLIP Beghin_Say Intl., Inc. EYQ Class I 1984-02-21
K834487 FLEXIBLE LIQUID LIGHT GUIDE Endo Lase, Inc. FFS Class II 1984-02-21
K834562 ENTERNAL FEEDING TUBE Sheridan Catheter Corp. KNT Class II 1984-02-13
K840019 K-TUBE REPAIR KIT Midwest Metabolic Support Group KNT Class II 1984-02-10
K834554 ETHOX WEIGHTED FEEDING TUBE Ethox Corp. KNT Class II 1984-02-10
K834448 URINARY DRAINAGE CONTAINER Vital Metrics, Inc. KNX Class II 1984-02-10
K834337 URIHESIVE SYSTEM - IMPROVED Convatec, A Division of E.R. Squibb & Sons KNX Class II 1984-02-10
K833780 CAPD PREP KIT Professional Dialysis Products FKG Class I 1984-02-09
K834504 ESKA JONAS SILICON-SILVER PENILE Dacomed Corp. FAE Class II 1984-02-04
K834402 GASTROINTESTINAL SHEATH BRUSH Hobbs Medical, Inc. FDX Class II 1984-02-04
K840166 SUR-FIT UROSTOMY POUCH W/ACCUSEAL Convatec, A Division of E.R. Squibb & Sons EXB Class I 1984-02-04
K840059 SILITEK URINARY DIVERSION STENT Surgitek FAD Class II 1984-02-04
K834296 ADULT INCONTINENCE BRIEF Procter & Gamble Mfg. Co. EYQ Class I 1984-02-04
K834589 BIOSPAL (R) 1800S Hospal Medical Corp. KDI Class II 1984-02-04
K834510 RENAFLO AVF SET FOR HEMODIALYSIS Renal Systems, Inc. KNZ Class II 1984-02-04
K834414 ERCP CANNULA Hobbs Medical, Inc. ODD Class II 1984-02-04
K834575 BARD KARAYA GUM WASHERS C.R. Bard, Inc. EXB Class I 1984-02-04
K840057 EXP* 500 PARALLEL PLATE DIALYZER Extracorporeal Medical Specialities, Inc. KOC Class II 1984-02-04
K834258 HODGE DECOMPRESSION TUBE Inmed Corp. KNT Class II 1984-02-04
K831784 HEMOFILTRATION SYSTEM Gambro, Inc. KDI Class II 1984-02-04
K840146 EXP* 700 PARALLEL PLATE DIALYZER Extracorporeal Medical Specialities, Inc. KOC Class II 1984-02-04
K834295 ADULT INCONTINENCE PAD Procter & Gamble Mfg. Co. EYQ Class I 1984-02-04
K832093 FEEDING GASTROSTOMY TUBE Tri-Med, Inc. KNT Class II 1984-02-04
K834451 COAXIAL BALLOON GASTROESOPHAGEAL DILA Thomas J. Fogarty, M.D. KNQ Class II 1984-02-04

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