meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
47
Latest Decision
1985-02-14

Clearances · page 98 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K844384 BILIARY STENT PROSTHESIS Mentor Corp. FGE Class II 1985-02-14
K844641 FRESENIUS HAEMODIALYSIS ;MACHINE A1008 Seratronics, Inc. FKQ Class II 1985-02-14
K850154 DIGNITY PANT & ABSORBENT PADS Convatec, A Division of E.R. Squibb & Sons EYQ Class I 1985-02-14
K850134 ENTRON ENTERAL FEEDING BAG Biosearch Medical Products, Inc. KNT Class II 1985-02-14
K843939 PEDIATRIC SIZE K-TUBE A OR B Midwest Metabolic Support Group KNT Class II 1985-02-14
K842039 ARGON DUAL LUMEN HEMODIALYSIS, CATHETER Argon Medical Corp. KNZ Class II 1985-01-29
K844748 NEPHROSS ALLEGRO H.F. Organon Teknika Corp. FKQ Class II 1985-01-22
K844341 UNITED SKIN BARRIER PASTE Howmedica Corp. EZR Class I 1985-01-18
K843683 MODULAR FIBERSCOPE SYSTEM Reichert Scientific Instruments GCP Class II 1985-01-18
K844504 SARTORIUS MINISART SM 16596HY Sartorius Filters, Inc. KOC Class II 1985-01-18
K844692 PEDIATRIC SIZED HEMOCATH CATHETER Quinton, Inc. FIQ Class II 1985-01-18
K844663 ASAHI NEW PAN-SERIES HEMOFILTERS Asahi Medical Co., Ltd. KDI Class II 1985-01-18
K843186 ESKA MULTISTAGE ESOPHAGEAL BOUGIE Dacomed Corp. FAT Class II 1985-01-18
K844938 UNITED SKIN BARRIERS Pfizer, Inc. EXB Class I 1985-01-18
K844155 STANDARD URINARY DRAINAGE BAG & LEG BAG Norris W. Whitlock KNX Class II 1985-01-16
K844756 ST FAMILY OF HOLLOW FIBER DIALYZERS Travenol Laboratories, S.A. FKQ Class II 1985-01-16
K844769 RIGID FIBEROPITC ENDOSCOPE Microvasive GCM Class II 1985-01-15
K844143 OLYMPUS PF-27M FLEXIBLE URETERORENOSCOPE Olympus Corp. FGB Class II 1985-01-15
K844801 ULTRA EXTERNAL CATHETER Inmed Corp. KNX Class II 1985-01-15
K845018 DAVOL ERCP CANNULA C.R. Bard, Inc. ODD Class II 1985-01-15
K845016 DAVOL POLYPECTOMY SNARE C.R. Bard, Inc. FDI Class II 1985-01-15
K845015 DAVOL PAPILLITOME C.R. Bard, Inc. KNS Class II 1985-01-15
K845017 DAVOL RETRIEVAL BASKETS & FORCEPS C.R. Bard, Inc. OCZ Class II 1985-01-15
K845010 CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH Chesebrough-Pond'S U.S.A. Co. EYQ Class I 1985-01-15
K844619 ENDONEEDLE Endotherapeutics FHO Class II 1985-01-09
K843866 HEMODIALYSATE SOLUTIONS Bicarbolyte Corp. KPO Class II 1985-01-09
K844684 COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM Coloplast A/S KNX Class II 1985-01-08
K844561 BARD URETEROSCOPIC CYTOLOGY BRUSH C.R. Bard, Inc. FDX Class II 1985-01-08
K844343 TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE Top Surgical Manufacturers Co. FIE Class II 1985-01-08
K844685 COLOPLAST URO 2002 UROSTOMY SYSTEM Coloplast A/S EXB Class I 1985-01-08
K844773 EFF-EFFNER BULBS Mecron Medical Products, Inc. FFS Class II 1985-01-08
K844108 RENAL SYSTEMS PERITONEAL ACCESS SYSTEM Renal Systems, Inc. FKX Class II 1985-01-07
K844745 K-TUBE Midwest Metabolic Support Group KNT Class II 1985-01-07
K843963 DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD Renal Systems, Inc. FKQ Class II 1985-01-07
K844074 HOBBS MEDICAL POLYPECTOMY SNARE Hobbs Medical, Inc. OCZ Class II 1985-01-03
K843442 URINARY DRAINAGE CONTAINER 2013 WITH Vital Metrics, Inc. FFG Class II 1985-01-03
K844551 HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT Gobbs Medical, Inc. FCL Class I 1985-01-03
K843084 OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE Olympus Corp. FBO Class II 1985-01-03
K844185 MODIFIED C-DAK Cd Medical, Inc. KOC Class II 1985-01-03
K843441 URINARY DRAINAGE CONTAINER 2012-WITH Vital Metrics, Inc. FFG Class II 1985-01-03
K844550 HOBBS MEDICAL/JAYCO ASPIRATION CATHETER Hobbs Medical, Inc. OCX Class II 1985-01-03
K844789 KANGAROO ACCESS II ENTERAL FEEDING CONTAINER Chesebrough-Pond'S U.S.A. Co. KNT Class II 1985-01-02
K844689 ENDOSCOPIC MANUAL AIR INSUFFLATOR Jayco Pharmaceuticals FCX Class II 1985-01-02
K844690 ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT Jayco Pharmaceuticals FCL Class I 1985-01-02
K843128 FEMALE URINARY INCONTINENCE SYS Chesebrough-Pond'S U.S.A. Co. KNX Class II 1985-01-02
K844503 UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK Epcom Medical Systems, Inc. FAP Class II 1985-01-02
K844175 ENTERNAL FEEDING TUBE-POLYURETHANE EF504 Exco, Inc. KNT Class II 1985-01-02
K844691 ENDOSCOPIC ASPIRATION CATHETER SET Jayco Pharmaceuticals OCX Class II 1985-01-02
K844203 ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403 Exco, Inc. KNT Class II 1985-01-02
K844280 TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE Travenol Laboratories, S.A. KNX Class II 1984-12-17
K844121 CLAMP, TUBING, LINE Dyn-A-Med Products FKK Class I 1984-12-17
K844612 ACUTE HEMODIALYSIS TRAYS Packaging Technologies, Inc. KNZ Class II 1984-12-17
K843698 CLOSED URINARY DRAINAGE UNIT Pathfinder Intl. Corp. KNX Class II 1984-12-17
K843101 KARL STORZ 27086KC ULTRASONIC LITHOTRI KARL STORZ Endoscopy-America, Inc. FEO Class II 1984-12-11
K842024 ULTRASONIC LITHOTRIPTOR 300A Fibra Sonics, Inc. FEO Class II 1984-12-11
K842174 PERCUTANEOUS GASTROSTOMY TUBE Mount Carmel Mercy Hospital KNT Class II 1984-12-07
K844174 FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI Exco, Inc. KNT Class II 1984-12-07
K843900 FOCUSCOPE UNIVERSAL SYSTEM Medical Diagnostics, Ca. GDB Class II 1984-12-06
K844222 BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR Biosearch Medical Products, Inc. KNT Class II 1984-12-05
K843478 PHARMA-PLAST URIDROP-URIDOME Zimmar Consulting , Ltd. KNX Class II 1984-12-05
K843477 PHARMA-PLAST RECTAL TIP Zimmar Consulting , Ltd. FCF Class II 1984-12-05
K843214 EPHAR Akron City Hospital FFI Class II 1984-11-29
K844046 UNITED SKIN BARRIERS Howmedica Corp. EXB Class I 1984-11-29
K844406 JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN Johnson & Johnson Professionals, Inc. EXB Class I 1984-11-29
K842420 NORTA SILICONIZED LATEX BALLOON CATH. Beiersdorf, Inc. KOD Class II 1984-11-21
K844030 ACCUMETER ELECTRONIC URINEMETER SYSTEM Travenol Laboratories, S.A. FFG Class II 1984-11-20
K843975 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE Superior Plastic Products Corp. KNT Class II 1984-11-20
K844144 SCD STERILE CONNECTION DEVICE E.I. Dupont DE Nemours & Co., Inc. FKX Class II 1984-11-16
K843869 TRANQUILITY Principle Business Ent. EYQ Class I 1984-11-16
K843623 UNILYTE A Medical Enterprises, Ltd. FKQ Class II 1984-11-16
K843531 ASN MONITOR SINGLE NEEDLE MONITOR Organon Teknika Corp. KOC Class II 1984-11-16
K842808 URITROL-M The Washington Group, Inc. KNT Class II 1984-11-16
K842690 SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT Synectics AB FFT Class I 1984-11-08
K842083 JIMMY JOHN III Colon Therapeutics KPL Class II 1984-10-24
K843280 MALLEABLE PENILE PROSTHESIS Mentor Corp. FAE Class II 1984-10-24
K843403 MOLINEA PANTY Paul Hartmann Corp. EYQ Class I 1984-10-19
K842547 WET-STOP Palco Laboratories, Inc. KPN Class II 1984-10-19
K843224 UROPUMP MODEL 1711 Life-Tech Intl., Inc. FFG Class II 1984-10-19
K843404 MOLINEA INCONTINENT PAD Paul Hartmann Corp. EYQ Class I 1984-10-19
K843405 MOLICARE Paul Hartmann Corp. EYQ Class I 1984-10-19
K843504 AMER. BENTLEY HEMOFILTER HOLDER HFH-1 American Bentley FKI Class II 1984-10-18
K842481 AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE American Edwards Laboratories LYK Class II 1984-10-18
K842885 EXTENDED LIFE CAPD SOLUTION TRANSFER Travenol Laboratories, S.A. FKX Class II 1984-10-18
K842810 INFRARED COAGULATOR Endo Lase, Inc. KNS Class II 1984-10-18
K841585 AMER. BENTLEY CONTINU-BLOOD PROCESSOR- American Bentley KDI Class II 1984-10-18
K843632 HOLLOW FIBER DIALYZER Travenol Laboratories, S.A. KOC Class II 1984-10-18
K843014 FRESENIUS HAEMODIALYSIS A2008 Seratronics, Inc. KDI Class II 1984-10-18
K843481 PHARMA-PLAST CONNECTING TUBE TYPE URIN- Zimmar Consulting , Ltd. KNX Class II 1984-10-18
K843479 PHARMA-PLAST LEG BAG Zimmar Consulting , Ltd. KNX Class II 1984-10-11
K843305 DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP C.R. Bard, Inc. KNT Class II 1984-10-11
K843392 GAUDERER GASTROSTOMY BUTTON American V. Mueller KNT Class II 1984-10-11
K843117 GREEN CROSS URINARY DRAINAGE BAG Tech-Cons Ltd., Intl. KNX Class II 1984-10-11
K843480 PHARMA-PLAST URINARY DRAINAGE BAG 2000 Zimmar Consulting , Ltd. KNX Class II 1984-10-11
K843126 MEDIFLEX DRAINAGE BAG Mediflex Intl. KNX Class II 1984-10-04
K843158 SEXTON CYSTOTOMY URINE PUMP Holter-Hausner Intl. KOB Class II 1984-10-04
K843520 WAREXIN RECOMMENDED ALTERNATIVE DIALYZ Mesa Medical, Inc. LIF Class II 1984-10-04
K843198 VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y Life-Tech Intl., Inc. FET Class II 1984-10-04
K842225 HEMODIAL CONCENTRATE MIXING APPARATUS Lmf Medical Research & Manufacturing, Inc. FKQ Class II 1984-10-02
K842639 AMER. EDWARDS LAB DIAFLEX URETERAL DILA American Edwards Laboratories EZN Class II 1984-10-02
K842632 DILATOR/SHEATH SET American Edwards Laboratories EZN Class II 1984-10-02

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