meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
44
Latest Decision
1990-03-22

Clearances · page 86 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K900323 PERITONEAL DIALYSIS CYCLER SET National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-22
K900140 DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-22
K900141 DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-22
K895991 PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-6 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-22
K895990 DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-22
K900012 DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-22
K900242 DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-22
K896600 DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-22
K900008 DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-22
K895168 URO-BAGGIE Cwt Workshop KNX Class II 1990-03-22
K900243 DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-6 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-22
K896599 DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8) National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-22
K900492 LABELING CHANGE - VIASPAN(TM) (BELZER UW) The DU Pont Co. KDL Class II 1990-03-20
K896060 ERECTION INDUCER DEVICE (EID) Performance Medical, Inc. LKY Class II 1990-03-20
K900086 HEMORRHOIDAL LIGATOR WITH SUCTION Baxter Healthcare Corp KDH Class II 1990-03-19
K900022 BJ STAR ALL SILICONE FOLEY BALLOON CATHETER B.J. Star, Inc. KOD Class II 1990-03-15
K900065 NON-ELECTRIC BIOPSY FORCEPS Esco Precision, Inc. FCL Class I 1990-03-15
K900015 NON-ELECTRIC BIOPSY FORCEPS Esco Precision, Inc. FCL Class I 1990-03-15
K894300 SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS U.S. Filter/Continental Water Systems FIP Class II 1990-03-13
K895824 L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SET Intl. Medical Marketing, Inc. FPD Class II 1990-03-13
K896559 INFANT FEEDING TUBE Westmark, Sterile Packing Systems, Inc. (Sps) FPD Class II 1990-03-13
K895159 INTRAVASCULAR IMAGING SYSTEM Intertherapy, Inc. LYK Class II 1990-03-12
K900035 WILSON-COOK COLON DECOMPRESSION SET Wilson-Cook Medical, Inc. FEG Class II 1990-03-07
K894459 ANGIOSCOPE Intramed Laboratories, Inc. LYK Class II 1990-03-07
K896448 BALLOON DILATION CATHETER Cook Ob/Gyn EZN Class II 1990-03-07
K896061 ERECTION DEVICE Clyde Engineering Service LKY Class II 1990-03-07
K900031 MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS Porges Corp. KNY Class II 1990-03-06
K896941 AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS American Medical Systems, Inc. FAE Class II 1990-03-06
K900005 DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-03-02
K896956 QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-02-27
K900004 CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-02-27
K900006 CATHETER ADAPTER SEALING CAP NO. 48-1028-9 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-02-27
K896806 CATHETER PLUG/PROTECTOR Westmark, Sterile Packing Systems, Inc. (Sps) KNY Class II 1990-02-26
K896761 TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-02-26
K896764 UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-02-26
K896726 4 SURE EXTERNAL MALE CATHETER The Boston & Pacific Co., Inc. KOD Class II 1990-02-26
K896763 CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-02-26
K896727 4 SURE URINARY DRAIN BAG The Boston & Pacific Co., Inc. KNX Class II 1990-02-20
K896728 4 SURE URINARY LEG BAG The Boston & Pacific Co., Inc. FAQ Class I 1990-02-20
K895772 EXEL INDWELLING CATHETER Exel Intl. FDZ Class I 1990-02-16
K896725 4 SURE UROLOGICAL CATHETER The Boston & Pacific Co., Inc. KOD Class II 1990-02-16
K896784 DISPOSABLE URODYNAMIC CATHETER SET Life-Tech Intl., Inc. KOD Class II 1990-02-16
K896160 WILLIAMS PENILE ANESTHETIC RETAINER Cook Urological, Inc. FHA Class I 1990-02-16
K896579 GOOSEN URINARY DRAINAGE SYSTEM Goosen Enterprises, Inc. KNX Class II 1990-02-15
K900439 SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC L H M Ent., Inc. FIH Class II 1990-02-15
K896680 PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC. Interson Corp. FED Class II 1990-02-14
K895852 BUZZY BEAR ENURESIS ALARM Med-Design, Inc. KPN Class II 1990-02-12
K895244 MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD. National Medical Care, Medical Products Div., Inc. KOC Class II 1990-02-12
K896691 BITE BLOCK Endoscopix MNK Class I 1990-02-12
K896612 DOBBHOFF(R) PAPILLOTOME Biosearch Medical Products, Inc. KNS Class II 1990-02-12
K896053 ALL SILICONE FOLEY CATHETER Rochester Medical Corp. KOD Class II 1990-02-12
K895420 SUCTION BIOPSY INSTRUMENT Mill-Rose Laboratory FCK Class II 1990-02-09
K895548 CONVEEN INTERMITTENT CATHETERS Coloplast A/S KOD Class II 1990-02-09
K895882 JMS DIALYZER PRIMING SET Jms Co., Ltd. KOC Class II 1990-02-09
K895885 AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING National-Standard Co. FCI Class II 1990-02-09
K895506 FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER Vas-Cath, Inc. LFJ Class II 1990-02-09
K896992 METAL URETERAL BASKET STONE DISLODGER Annex Medical, Inc. FFL Class II 1990-02-08
K896518 DOBBHOFF(R) ERCP CANNULA Biosearch Medical Products, Inc. FGE Class II 1990-02-02
K893816 HEMOLASER HEMOSCOPE Hemolaser Corp. LYK Class II 1990-02-01
K900125 ARTERIOVENOUS FISTULA SETS Baxter Healthcare Corp FIE Class II 1990-01-31
K896581 PEDIATRIC DRAIN BAG Laytech Medical Co. FFH Class II 1990-01-31
K896505 PORGES UNIVERSAL HANDLES Porges Corp. GCP Class II 1990-01-30
K896503 PORGES ERCP CATHETERS Porges Corp. FGE Class II 1990-01-30
K896507 PORGES DIATHERMY SNARE Porges Corp. KNS Class II 1990-01-29
K895673 CONNECTION SHIELDS CODES 5C4213 AND 5C4215 Baxter Healthcare Corp KDJ Class II 1990-01-29
K896573 EASI-LAV ADULT GASTRIC LAVAGE KIT Clairson Industries, LLC KDH Class II 1990-01-29
K895631 DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466 Baxter Healthcare Corp KDJ Class II 1990-01-29
K896252 MODIFIED QUINTON SINGLE LUMEN CATHETER Quinton, Inc. MPB Class II 1990-01-29
K896425 PORGES CYTOLOGY BRUSHES Porges Corp. FDX Class II 1990-01-29
K896424 PORGES SCLEROTHERAPY NEEDLES Porges Corp. FBK Class II 1990-01-26
K896506 PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR Porges Corp. FGE Class II 1990-01-26
K896504 PORGES 2-WAY BALLOON EXTRACTION CATHETER Porges Corp. FGE Class II 1990-01-26
K896212 URETHRAL CATHETERIZATION TRAYS Westmark, Sterile Packing Systems, Inc. (Sps) FCM Class II 1990-01-24
K895080 SURGICAL GLOVES Jet Far Industries, Inc. FGO Class II 1990-01-24
K896376 PORGES NASOBILIARY DRAIN Porges Corp. FGE Class II 1990-01-22
K896423 PORGES BILIARY STENTS Porges Corp. FGE Class II 1990-01-22
K896502 PORGES BIOPSY & FOREIGN BODY FORCEPS Porges Corp. OCZ Class II 1990-01-22
K896385 URETERAL ACCESS SET Applied Urology, Inc. KOD Class II 1990-01-22
K893522 SURGEON'S GLOVES Thai Fuji Latex Co., Ltd. FGO Class II 1990-01-22
K896426 PORGES SPHINCTEROTOMES Porges Corp. KNS Class II 1990-01-22
K895855 PHOENIX Medical and Scientific Enterprises, Inc. KNS Class II 1990-01-22
K896210 GASTRIC SUMP TUBE Westmark, Sterile Packing Systems, Inc. (Sps) KNT Class II 1990-01-18
K896211 CYSTOSCOPY/IRRIGATION SET Westmark, Sterile Packing Systems, Inc. (Sps) KOD Class II 1990-01-18
K896213 Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET Westmark, Sterile Packing Systems, Inc. (Sps) KOD Class II 1990-01-18
K896208 CYSTO PUMP DRAINAGE BAG Westmark, Sterile Packing Systems, Inc. (Sps) KOD Class II 1990-01-18
K894618 INAMED RHEMO-D (TM) DILATOR Inamed Development Co. FFP Class I 1990-01-18
K895405 AMICON MINIFILTER PLUS HEMOFILTER Amicon, Inc. KDI Class II 1990-01-11
K893991 HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS P & A Co. KPO Class II 1990-01-11
K895900 WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE Wilson-Cook Medical, Inc. FCK Class II 1990-01-11
K895842 BITOME(TM) BIPOLAR SPHINCTEROTOME Everest Medical Corp. KNS Class II 1990-01-11
K895417 ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT Arrow Intl., Inc. LFJ Class II 1990-01-03
K896058 GRASPING FORCEPS Annex Medical, Inc. KOA Class I 1989-12-28
K896008 MODEL 6500 MERCURY ARC LIGHT SOURCE Medical Dynamics, Inc. GCP Class II 1989-12-27
K896006 DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095 Baxter Healthcare Corp KOC Class II 1989-12-27
K896111 FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB Fresenius USA, Inc. KPO Class II 1989-12-27
K894862 WILTEK GRASPING FORCEPS Wiltek Medical, Inc. OCZ Class II 1989-12-21
K894868 WILTEK VARICES INJECTION NEEDLE Wiltek Medical, Inc. FBK Class II 1989-12-21
K894865 WILTEK BALLOON STONE EXTRACTOR Wiltek Medical, Inc. LQR Class II 1989-12-21
K894870 WILTEK NASAL BILIARY DRAINAGE SET Wiltek Medical, Inc. BSS Class II 1989-12-21
K894861 WILTEK PAPILLOTOME Wiltek Medical, Inc. KNS Class II 1989-12-21

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