meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
52
Latest Decision
1990-10-19

Clearances · page 84 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K903994 URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION Applied Urology, Inc. FGF Class II 1990-10-19
K903668 WILSON-COOK ASPIRATION HANDLE Wilson-Cook Medical, Inc. FBK Class II 1990-10-15
K902240 VET (VACUUM ERECTION TECHNOLOGY) Vetco, Inc. LKY Class II 1990-10-12
K903858 COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION Cook, Inc. FGE Class II 1990-10-10
K903340 STERILE URETHRAL CATHETER PROCEDURE KITS Superior Healthcare Group, Inc. FCM Class II 1990-10-04
K895650 ENTERAL PUMP SET W/ENTERA-FLO SPIKE Delmed, Inc. KNT Class II 1990-10-02
K895329 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA Delmed, Inc. KNT Class II 1990-10-02
K895142 ENTERAL PUMP SET WITH ENTERAL SPIKE Delmed, Inc. KNT Class II 1990-10-02
K902320 BAUER FLEXI-TEMNO BIOPSY NEEDLE Proact, Ltd. FCG Class II 1990-10-01
K902641 RPI ENTERAL FEEDING BAG 1000ML AND 500ML Ridge Products, Inc. KNT Class II 1990-10-01
K903323 RESECTOSCOPE LOOPS Olympus Corp. KNS Class II 1990-10-01
K896758 GAMBRO BICARBONATE MONITOR BCM 10-3 Gambro, Inc. FKP Class II 1990-09-28
K903834 N. M. BEALE COMPANY VU-THRU WATER BOTTLE N.M. Beale Co., Inc. OCX Class II 1990-09-24
K903567 BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F. Organon Teknika Corp. FJI Class II 1990-09-24
K902274 CUSTOMED CYSTO PACK I Customed, Inc. FAJ Class II 1990-09-20
K902843 BIOSEARCH ANAL BIOFEEDBACK DEVICE Biosearch Medical Products, Inc. FAP Class II 1990-09-14
K902692 DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002 Diagnostic Ultrasound Corp. FAP Class II 1990-09-13
K901734 SERIM RESIDUAL CHLORINE TEST KIT Serim Research Corp. FKJ Class II 1990-09-13
K903449 URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET Uresil Corp. EXF Class II 1990-09-12
K902788 CLEM TM Arbo Medical, Inc. FIB Class II 1990-09-12
K902944 WITTICH NITINOL STONE BASKET Cook, Inc. LQR Class II 1990-09-12
K903856 WET-NO-MORE MONITOR Travis Industries, Inc. KPN Class II 1990-09-12
K902684 MIC ANAL INCONTINENCE TUBE Medical Innovations Corp. KNT Class II 1990-09-12
K902945 COPE NITINOL STONE BASKET Cook, Inc. LQR Class II 1990-09-12
K901907 PROFESSIONAL MONITOR Travis Industries, Inc. KPN Class II 1990-09-12
K902319 BAUER TEMNO BIOPSY NEEDLE Proact, Ltd. FCG Class II 1990-09-06
K902066 DISPOSABLE BIOPSY FORCEP FOR FLEXIBLE ENDOSCOPES Endo-Scientific, Inc. KNW Class II 1990-09-06
K901835 LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR) Lake Medical Products, Inc. KNT Class II 1990-09-05
K902949 CORPAK GRASPING FORCEPS Corpak Co. OCZ Class II 1990-08-30
K896757 GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS Gambro, Inc. FKP Class II 1990-08-30
K902585 UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER Advanced Surgical Intervention, Inc. KOE Class II 1990-08-27
K902736 NM INJECTION NEEDLES Olympus Corp. FBK Class II 1990-08-24
K902737 BC BRUSHES Olympus Corp. FDX Class II 1990-08-24
K902508 LAKE MALE EXTERNAL CATHETERIZATION KIT Lake Medical Products, Inc. FCM Class II 1990-08-23
K902734 PR CANNULAS Olympus Corp. FGE Class II 1990-08-22
K902329 ULTRA-VU ANGIOSCOPE Angiolaz, Inc. LYK Class II 1990-08-22
K901360 LEVEEN PERITINEO-VENOUS SHUNT Bd Becton Dickinson Vacutainer Systems Preanalytic KPM Class II 1990-08-21
K902370 MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER Boston Scientific Corp FAH Class II 1990-08-17
K903021 NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630 National Medical Care, Medical Products Div., Inc. FJK Class II 1990-08-14
K902451 LONG-LIFE Y-SET CAT. NO. 48-6366-8 National Medical Care, Medical Products Div., Inc. KDJ Class II 1990-08-14
K902408 DIAGNOSTIC ULTRASOUND UFS 1005 Diagnostic Ultrasound Corp. EXY Class II 1990-08-10
K902124 DOWD CATHETER Boston Scientific Corp FAH Class II 1990-08-09
K902729 R.P.I. GRAVITY SAFE FEEDING BAG Ridge Products, Inc. KNT Class II 1990-08-08
K901795 GASTROSTOMY FEEDING CATHETER Southside Biotechnology KGC Class II 1990-08-08
K901791 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH. Southside Biotechnology KGC Class II 1990-08-08
K901464 MEDILASE SERIES 2200 ENDOSCOPE Medical Laser, Inc. GCM Class II 1990-08-07
K902400 WILSON-COOK RETRIEVAL & GRASPING FORCEPS Wilson-Cook Medical, Inc. OCZ Class II 1990-08-07
K896750 LOFRIC(R), LOFRIC(R) CATH-KIT Astra Meditec AB KOD Class II 1990-08-06
K900324 DOBBHOFF WIRE GUIDED JEJUNAL FEEDING TUBE Biosearch Medical Products, Inc. KNT Class II 1990-08-02
K900563 DOBBHOFF(R) ENDOENTERIC GASTRIC DECOMPRESSION CATH Biosearch Medical Products, Inc. KNT Class II 1990-08-02
K901368 HEMOSPAL KITS A1, A2D, AO, & A1D Gambro-Hospal, Inc. FJG Class II 1990-08-02
K900590 BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING Biosearch Medical Products, Inc. KNT Class II 1990-08-02
K900624 DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING SYSTEM Biosearch Medical Products, Inc. KNT Class II 1990-08-02
K901688 ARTERIAL/VENOUS BLOODLINES National Medical Care, Medical Products Div., Inc. FJK Class II 1990-08-02
K902203 TENCKHOFF PERITONEAL DIALYSIS KIT Akcess Medical Products, Inc. FJG Class II 1990-08-01
K902265 FLEXIBLE SNARE Annex Medical, Inc. FDI Class II 1990-07-27
K900018 HOLLOW FIBER DIALYZER, BIO CARE PS 130 National Medical Care, Medical Products Div., Inc. KDI Class II 1990-07-27
K900058 WILSON-COOK BILIARY MOTILITY CATHETER Wilson-Cook Medical, Inc. FFX Class II 1990-07-27
K901473 GC-01 THROUGH GC-99 ACETATE CONCENTRATE Granite Chemical Co., Inc. KPO Class II 1990-07-27
K902121 LAKE GASTROSTOMY TUBE Lake Medical Products, Inc. KGC Class II 1990-07-27
K901472 GC-BC-01, GC-BC-02, GC-BC-03 BICARBONATE DRY PACKS Granite Chemical Co., Inc. KPO Class II 1990-07-27
K902097 MODEL TR RECTAL SUCTION BIOPSY TUBE Medical Measurements, Inc. FCK Class II 1990-07-27
K902101 PERITONEAL CATHETERS Akcess Medical Products, Inc. FJS Class II 1990-07-27
K901478 DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION Delmed, Inc. FKX Class II 1990-07-27
K901471 GC-1000 THROUGH GC-3005 ACID CONCENTRATE Granite Chemical Co., Inc. KPO Class II 1990-07-27
K902077 T19S BIOPSY NEEDLE Ohio Medical Instrument Co., Inc. KNW Class II 1990-07-27
K901477 DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION Delmed, Inc. FKX Class II 1990-07-27
K902481 GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER Gambro, Inc. FJI Class II 1990-07-27
K901409 TRANSDUCER PROTECTOR Filtertek, Inc. FIB Class II 1990-07-27
K902170 SOEHENDRA LITHOTRIPSY SET Wilson-Cook Medical, Inc. LQC Class II 1990-07-25
K901181 CATHETER CARE TRAY Orion Life Systems, Inc. FCM Class II 1990-07-20
K901185 FOLEY CATHETER INSERTION TRAY (10CC) Orion Life Systems, Inc. FCM Class II 1990-07-20
K901184 URETHRAL CATHETER TRAY (LATEX) Orion Life Systems, Inc. FCM Class II 1990-07-20
K901183 URETHRAL CATHETER TRAY (PVC) Orion Life Systems, Inc. FCM Class II 1990-07-20
K901180 FOLEY CATHETER INSERTION TRAY (30CC) Orion Life Systems, Inc. FCM Class II 1990-07-20
K895923 METRICARE ENTERAL FEEDING SYSTEM Metrix Co. FPD Class II 1990-07-19
K901435 GASTROINTESTINAL CYTOLOGY BRUSH Telemed Systems, Inc. FDX Class II 1990-07-16
K902417 BAG, URINE Gainor Medical Europe, Ltd. KNX Class II 1990-07-16
K900239 WILSON-COOK ESOPHAGEAL MOTILITY CATHETER Wilson-Cook Medical, Inc. KLA Class II 1990-07-16
K902461 MEADOX SURGIMED BIOPSY GUN AND NEEDLE Meadox Surgimed, Inc. KNW Class II 1990-07-16
K902773 SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET Medical Engineering Corp. FGB Class II 1990-07-16
K902107 WILSON-COOK SYRINGE HOLDERS Wilson-Cook Medical, Inc. FGE Class II 1990-07-16
K900918 GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER Gambro, Inc. KDI Class II 1990-07-16
K900106 CLOSED DISCONNECT SYSTEM Delmed, Inc. KDJ Class II 1990-07-16
K896322 CN GAURD, STERILE LATEX SURGICAL GLOVES C.N. Technocrats FGO Class II 1990-07-12
K901906 WET-NO-MORE MONITOR Travis Industries, Inc. KPN Class II 1990-07-11
K900341 SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT Serim Research Corp. LIF Class II 1990-07-11
K900269 PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE Porges Corp. FFL Class II 1990-07-03
K901023 GASTROINTESTINAL TUBES AND ACCESSORIES Medline Industries, Inc. KNT Class II 1990-07-02
K900884 P.R.G. PERCUTANEOUS REPLACEMENT GASTROSTOMY Applied Medical Technologies KGC Class II 1990-07-02
K901574 ACKRAD MPR DRAINAGE CATHETER SET Ackrad Laboratories KNT Class II 1990-06-29
K901610 SULLIVAN VARIABLE STIFFNESS CABLE Wilson-Cook Medical, Inc. FDF Class II 1990-06-29
K901182 ENEMA BAG SET Orion Life Systems, Inc. FCE Class I 1990-06-28
K901179 ENEMA BUCKET SET Orion Life Systems, Inc. FCE Class I 1990-06-28
K901219 EXTERNAL LEG BAG Orion Life Systems, Inc. FAQ Class I 1990-06-27
K901738 SELFCATH Vitaid, Ltd. KOD Class II 1990-06-27
K900082 MAXX 470 CORE BIOPSY GUN Dlp, Inc. KNW Class II 1990-06-27
K901683 IMPROVED BAKER TWIN-CUFF SUMP TUBE Bissell Medical Products, Inc. KNT Class II 1990-06-27
K901482 700 ULTREX PENILE PROSTHESIS 12MM DIAMETER American Medical Systems, Inc. FAE Class II 1990-06-27
K900894 MEDILASE SERIES 2100 ENDOSCOPE Medical Laser, Inc. GCQ Class II 1990-06-22

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