meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
52
Latest Decision
1988-07-28

Clearances · page 90 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K882673 SIGMA 1 WOBBLER BIOPSY KIT Kontron Instruments, Inc. FCH Class I 1988-07-28
K881213 GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER Geneva Laboratories, Inc. KNX Class II 1988-07-28
K881218 GENT-L-KARE CLEANSING ENEMA SET Geneva Laboratories, Inc. FCE Class I 1988-07-28
K881885 BATTERY PACKS (OTHER THAN CV) Dowit Service Co., Inc. FCP Class I 1988-07-26
K880775 CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY Medsurg Industries, Inc. LFK Class II 1988-07-25
K882680 ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA Baxter Healthcare Corp FJI Class II 1988-07-22
K882549 ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI. Acuson Corp. FCG Class II 1988-07-21
K881720 JIMMY JOHN III Colon Therapeutics KPL Class II 1988-07-20
K880778 MEDSURG ACUTE DIALYSIS TRAY Medsurg Industries, Inc. LFJ Class II 1988-07-15
K882498 EXTENDED LIFE CAPD TRANSFER SET 5C4444 Baxter Healthcare Corp KDJ Class II 1988-07-13
K881978 ENTERAL FEEDING TUBES Primrose Medical, Inc. KNT Class II 1988-07-13
K882455 EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373 Baxter Healthcare Corp KDJ Class II 1988-07-13
K881636 CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) Coloplast A/S EXB Class I 1988-07-13
K882466 VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER Vas-Cath, Inc. LFK Class II 1988-07-13
K881706 PROXIMA 1 PH MONITOR Technomanagement, Inc. C/O C.G. FFT Class I 1988-07-12
K882641 TECNOL CATHETER LEG STRAP Tecnol New Jersey Wound Care, Inc. KNY Class II 1988-07-12
K881609 SITZMARKS Lafayette Pharmacal, Inc. FFX Class II 1988-07-08
K882213 NEPHROSS I.Q. ALLEGO Organon Teknika Corp. FJI Class II 1988-06-28
K882215 NEPHROSS I.Q. MODERATO Organon Teknika Corp. FJI Class II 1988-06-28
K882339 BIO*NEPHROSS I.Q. ANDANTE Organon Teknika Corp. FJI Class II 1988-06-28
K881363 SYRINGE PREFILLED WITH WATER I M, Inc. KOD Class II 1988-06-23
K881695 DESERET SUBCLAVIAN HEMODIALYSIS CATHETER Deseret Medical, Inc. LFJ Class II 1988-06-23
K881743 VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER Vas-Cath, Inc. LFJ Class II 1988-06-23
K880570 DENVER PLEURO-PERITONEAL SHUNT Codman & Shurtleff, Inc. KPM Class II 1988-06-20
K880504 MCT MEDICAL BROWNE UROSCAN URODYNAMIC Mct Medical, Inc. EXY Class II 1988-06-17
K873606 MODIFIED COPE SUTURE ANCHOR Cook, Inc. FGE Class II 1988-06-17
K882297 1/2 CM REAR TIP EXTENDER (RTE) American Medical Systems, Inc. FHN Class II 1988-06-17
K880503 MDL-1 LASERTRIPTER Candela Laser Corp. FFK Class II 1988-06-17
K881646 UROLOGICAL CATHETER Coeur Laboratories, Inc. KOD Class II 1988-06-16
K880454 AT EASE STRESS PAD Hospital Specialty Co. EYQ Class I 1988-06-16
K881097 SPEC 5* SUPRAPUBIC CATHETER Porges Corp. KOB Class II 1988-06-03
K881162 ENTERA* ENTERAL FEEDING BAG Smash Ent., Inc. KNT Class II 1988-06-03
K875232 INTRO-REDUCER (NASOGASTRIC TUBE) Health Improvement Assoc. KNT Class II 1988-06-02
K880401 DENVER PERITONEO-VENOUS SHUNT Codman & Shurtleff, Inc. KPM Class II 1988-05-31
K880102 BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS Baxter Healthcare Corp KPO Class II 1988-05-26
K880850 KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE Kmb Medical Products Co. FEG Class II 1988-05-26
K880801 SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 Medical Engineering Corp. FGB Class II 1988-05-26
K880802 SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 Medical Engineering Corp. FGB Class II 1988-05-26
K881310 DENT SLEEVE MANOMETRIC CATHETER Wilson-Cook Medical, Inc. KNT Class II 1988-05-20
K881957 HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT N-S Medical Products KNW Class II 1988-05-20
K881956 NATIONAL-STANDARD NEEDLE HOLDER N-S Medical Products KNW Class II 1988-05-20
K880306 EMERGENCY-CLEAN UP(TM) ECP Cdc Products Corp. EXB Class I 1988-05-20
K881004 OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR Keymed, Inc. FCX Class II 1988-05-12
K881744 PORGES URETERAL STENT Bivona Medical Technologies FAD Class II 1988-05-03
K874154 ELECATH(R) TRANSESOPHAGEAL PACING CATHETER Electro-Catheter Corp. KNT Class II 1988-04-29
K881290 MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA Shiley, Inc. LFJ Class II 1988-04-27
K881332 DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH Baxter Healthcare Corp OCZ Class II 1988-04-27
K874084 MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM National Medical Care, Medical Products Div., Inc. FKQ Class II 1988-04-27
K880391 DACOMED CYSTOMETER Dacomed Corp. EXQ Class II 1988-04-27
K874573 FRESENIUS PURISTERIL 340 (TM) Seratronics, Inc. LIF Class II 1988-04-25
K880768 MIC (SPECIFIC LINE) REPLACEMENT KIT Medical Innovations Corp. KNT Class II 1988-04-22
K881098 MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METER Automata, Inc. FIZ Class II 1988-04-21
K881062 CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 Cobe Laboratories, Inc. FJB Class II 1988-04-21
K880201 REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600 Superior Healthcare Group, Inc. KNT Class II 1988-04-14
K880660 SURGITEK SUPER DOUBLE J URETERAL STENT KIT Surgitek FAD Class II 1988-04-14
K880337 MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 Plasco, Inc. FCE Class I 1988-04-14
K880455 AT EASE ADULT DIAPER Hospital Specialty Co. EYQ Class I 1988-04-14
K874936 MEDSURG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY Medsurg Industries, Inc. KNT Class II 1988-04-14
K874759 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE Dantec Electronics, Inc. FAP Class II 1988-04-14
K874758 DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE Dantec Electronics, Inc. FAP Class II 1988-04-14
K880051 ENTERAL BAG/SET Churchill Corp. KNT Class II 1988-04-14
K880459 480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE Cd Medical, Inc. FKP Class II 1988-04-13
K881399 3 FRENCH FLEXIBLE BIOPSY FORCEPS Cook Urological, Inc. OCZ Class II 1988-04-11
K874137 MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR Ash Medical Systems, Inc. FKT Class II 1988-04-08
K880648 ENDOSCOPIC ELASTIC BAND LIGATOR Superior Healthcare Group, Inc. FHN Class II 1988-04-06
K875171 J-CATH(TM) Hdc Corp. KNT Class II 1988-04-06
K874755 EFFNER FE-EX* OROGASTRIC Effner and Spreine Co. KNT Class II 1988-04-06
K880338 CHICOPEE ADULT INCONTINENCE SHIELDS Chicopee, Inc. EYQ Class I 1988-03-31
K873360 ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG Endovations KNT Class II 1988-03-30
K875264 WASHING CATHETER Endovations OCX Class II 1988-03-29
K874680 LASEGUIDE 600A, 600B, 400A, AND 400B Laser Peripherals, LLC FCS Class II 1988-03-23
K880071 SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE Laserguide FCS Class II 1988-03-22
K872712 PC POLYGRAF Synectics-Dantec KLA Class II 1988-03-18
K872059 DRIPRIDE PROVIDE ULTRA Weyerhaeuser Co. EYQ Class I 1988-03-16
K880726 JMS APHERESIS NEEDLE Jms Co., Ltd. FIE Class II 1988-03-16
K871242 REVERSE OSMOSIS WATER PURIFICATION SYSTEM Medro Systems, Inc. FIP Class II 1988-03-16
K880100 COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING Cook Urological, Inc. KOD Class II 1988-03-15
K880253 BLAKEMORE RETAINER Orthopedic Systems, Inc. FEF Class II 1988-03-11
K875383 LAKE CATHETER CARE KITS (MODIFICATION) Lake Medical Products, Inc. KOD Class II 1988-03-09
K880232 NH REPLACEMENT GASTROSTOMY KIT Biosearch Medical Products, Inc. KNT Class II 1988-03-03
K875038 MENTOR UNISTENT URETERAL STENT SET Mentor Corp. FAD Class II 1988-03-03
K880096 VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP Van-Tec, Inc. KNW Class II 1988-03-02
K875188 LUER LOCK CONNECTORS / RIDIG P.V.C. Vas-Cath of Canada , Ltd. LFJ Class II 1988-03-02
K880095 BERGER PROSTATE CULTURE CYTOLOGY BRUSH Van-Tec, Inc. FDX Class II 1988-03-02
K880098 VAN-TEC AUTO BIOPSY NEEDLE Van-Tec, Inc. KNW Class II 1988-03-02
K875126 MIC (SPECIFIC LINE) INSERTION KIT Medical Innovations Corp. KNT Class II 1988-03-02
K880034 CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT Lin-Mark, Inc. KNX Class II 1988-03-02
K875119 BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE Advanced Diagnostic Medical Systems, Inc. FCI Class II 1988-03-02
K880099 VAN-TEC BLADDER EVACUATOR Van-Tec, Inc. KQT Class II 1988-03-02
K871313 ULTRA-FRESH DEODORANT Mentor Corp. GDS Class I 1988-03-02
K880583 MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH Quinton, Inc. MPB Class II 1988-02-22
K874872 FRESENIUS HEMOFLOW F3, F4, F5, F7 Seratronics, Inc. FJI Class II 1988-02-19
K874858 LASERTRIPTER MINISCOPE Candela Laser Corp. ODF Class II 1988-02-19
K880084 GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS Gambro, Inc. FJI Class II 1988-02-19
K875121 AMICON EQUALINE FLUID BALANCE SYSTEM Amicon, Inc. KPF Class II 1988-02-19
K880327 MARLEN ULTRA ILEOSTOMY POUCH-5000 Marlen Mfg. & Development Co. EZQ Class I 1988-02-19
K875312 UFR DIGITAL RETROFIT Yankee Intl. Medical Research & Mfg., Ltd. FJB Class II 1988-02-19
K874633 PERMCATH INSERTION TRAY Quinton, Inc. LFJ Class II 1988-02-17
K874112 VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER Van-Tec, Inc. KOD Class II 1988-02-11
K873557 MENTOR BLACK LIGHT URETERAL STENT SET Mentor Corp. FAD Class II 1988-02-11

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