meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
49
Latest Decision
1988-02-08

Clearances · page 91 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K874690 GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER Mentor Corp. FFX Class II 1988-02-08
K874709 DIAMOND MEDICAL, INC. MODEL DM 800 Diamond Medical, Inc. FFT Class I 1988-02-08
K874710 DIAMOND MEDICAL, INC. MODEL DM 600 Diamond Medical, Inc. FFT Class I 1988-02-08
K875369 MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT Diamond Medical, Inc. FFT Class I 1988-02-05
K874493 BELLA - VAC IRRIGATOR Bel-Can Industries KQT Class II 1988-02-05
K871848 NUTRITION DELIVERY SETS FOR VM 05 AMBULA. PUMP Panamedix, Inc. KNT Class II 1988-02-03
K874867 CATR(TM)-H CARDIOTOMY HOLDER Bentley Laboratories, Inc. KPI Class II 1988-02-02
K874020 ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE Abbott Laboratories KPF Class II 1988-01-29
K874728 CAPILLARY FLOW DIALYZERS Baxter Healthcare Corp FJI Class II 1988-01-29
K873954 NAMIC HAWKINS UNIVERSAL DRAINAGE SET North American Instrument Corp. FGE Class II 1988-01-29
K874549 NEPHROSS I.Q. ANDANTE Organon Teknika Corp. FJI Class II 1988-01-29
K874530 URETHRAL DILATOR ENDOSCOPE Advanced Surgical Intervention, Inc. KOB Class II 1988-01-27
K874682 MMG CATHETER PLUG W/DRAINAGE TUBE COVER Medical Marketing Group KOD Class II 1988-01-27
K880083 GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS Gambro, Inc. FJI Class II 1988-01-27
K873695 MODEL 1859 TUMI/PRESSURE MODULE Life-Tech Intl., Inc. EXY Class II 1988-01-27
K872522 BED ALERT Nite Train-R Enterprises, Inc. KPN Class II 1988-01-19
K873036 ATTENDS INCONTINENT BRIEF Procter & Gamble Mfg. Co. EYQ Class I 1988-01-19
K871712 MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. Machida America, Inc. NVE Class II 1988-01-14
K873795 M-LENS (THIRTY DEGREE ENDOSCOPE) Opto Vision, Inc. FEI Class I 1988-01-14
K874525 MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR Mon-A-Therm, Inc. KOD Class II 1988-01-06
K874062 ENTERON LIVER BIOPSY TRAY Endovations KNW Class II 1987-12-31
K873248 GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS Medical Engineering Laboratory, Inc. OCZ Class II 1987-12-30
K873166 BCM DRY PACK BICARBONATE MIXER Specialty Dialysis Services FIN Class II 1987-12-30
K873996 CAREY CAPSULE Wilson-Cook Medical, Inc. KNW Class II 1987-12-29
K874009 OVAL CUP HOT BIOPSY FORCEP (MODEL C-52) Endovations OCZ Class II 1987-12-29
K874010 ROUND CUP HOT BIOPSY FORCEP (MODEL D-52) Endovations OCZ Class II 1987-12-29
K873643 GAMBRO ADSORBA 150C Gambro, Inc. FLD Class II 1987-12-29
K874632 BENT NECK CURLCATH PERITONEAL DIALYSIS KIT Quinton, Inc. FKX Class II 1987-12-29
K872294 COMBINATION NITE DRAINAGE UNIT Arnold Technologies EXB Class I 1987-12-29
K874014 OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1) Endovations OCZ Class II 1987-12-29
K874007 OVAL CUP HOT BIOPSY FORCEP (MODEL A-51) Endovations OCZ Class II 1987-12-29
K872767 FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER Hospal Medical Corp. KDI Class II 1987-12-29
K874239 CLEANING BRUSH Endovations MNL Class I 1987-12-29
K874005 RAT TOOTH GRASPING FORCEP (MODEL 23/20) Endovations OCZ Class II 1987-12-29
K874013 OVAL CUP BIOPSY FORCEP(23/5) USED W/COLONOSCOPE Endovations OCZ Class II 1987-12-29
K874008 OVAL CUP HOT BIOPSY FORCEP (MODEL B-51) Endovations OCZ Class II 1987-12-29
K874012 OVAL CUP BIOPSY FORCEP (MODEL 18/5) Endovations OCZ Class II 1987-12-29
K874003 HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 18/12) Endovations OCZ Class II 1987-12-29
K874015 HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 23/12) Endovations OCZ Class II 1987-12-29
K874004 ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125) Endovations OCZ Class II 1987-12-29
K874312 ACKRAD RETROGRADE URETHROGRAPHY SET Ackrad Laboratories KOD Class II 1987-12-29
K874011 OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1) Endovations OCZ Class II 1987-12-29
K874293 ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET Ackrad Laboratories KOD Class II 1987-12-29
K874016 OVAL CUP BIOPSY FORCEP(23/5) USED W/GASTRO/SIGOIDO Endovations OCZ Class II 1987-12-29
K874006 GRASPING TRIPOD FORCEP (MODEL 23/25) Endovations OCZ Class II 1987-12-29
K873887 MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL. W.R. Grace & Co.-Conn. KDI Class II 1987-12-09
K874650 PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) Quinton, Inc. FKO Class II 1987-12-09
K873343 ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM Entech, Inc. KNT Class II 1987-12-07
K874309 URETHAL CATHETER Medovations, Inc. KNX Class II 1987-12-07
K874164 GUIDE WIRE Endovations EZB Class I 1987-12-07
K874314 WILSON-COOK BIOPSY FORCEPS Wilson-Cook Medical, Inc. KNW Class II 1987-12-07
K874393 ENTERAL FEEDING TUBE Wilson-Cook Medical, Inc. KNT Class II 1987-12-07
K873448 FOLEY CATHETER TEMPERATURE SENSOR Respiratory Support Products, Inc. KOD Class II 1987-12-07
K874517 PHARMASEAL RUBBER URETHRAL CATHETER American Pharmaseal Div. Ahsc KOD Class II 1987-12-03
K874410 CUMEVAC Cumes-Honikman Partnership FFD Class I 1987-12-03
K873929 'CATCH-IT' OR FECAL CONTAINMENT DEVICE Midwest Medical Co. EXB Class I 1987-12-03
K872921 MSS ENTERAL DELIVERY SET Medical Support, Inc. KNT Class II 1987-12-03
K874045 PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER American Pharmaseal Div. Ahsc NWU Class II 1987-12-03
K873367 OLYMPUS LUS ULTRASONIC LITHOTRIPTER Olympus Corp. FEO Class II 1987-11-30
K873288 CLOSED FOLEY CATHETER SYSTEM Todd Medical, Inc. KNY Class II 1987-11-27
K872006 DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF Mac Lee Medical Products FGD Class II 1987-11-17
K873287 IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE) Todd Medical, Inc. KOD Class II 1987-11-13
K873441 BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE Bissell Medical Products, Inc. KNT Class II 1987-10-27
K873155 GAMBRO BICART SYSTEM Gambro, Inc. FKP Class II 1987-10-26
K873279 8810 PUMP-PUMP SINGLE NEEDLE DEVICE Cd Medical, Inc. FIF Class II 1987-10-23
K873487 HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES Water Pure, Inc. FIP Class II 1987-10-23
K874034 ADR-22 AUTOMATIC DIALYZER REPROCESSOR Biodynamics Corp. LIF Class II 1987-10-23
K873984 AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) Travenol Laboratories, S.A. KDJ Class II 1987-10-20
K871922 PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA. Chemfet Corp. FFT Class I 1987-10-20
K873369 SECURLINE FRANSEENE NEEDLE Precision Dynamics Corp. KNW Class II 1987-10-20
K871921 GENERAL PURPOSE COMBINATION PH ELECTRODE Chemfet Corp. FFT Class I 1987-10-20
K873176 HUFFMAN BIOPSY UNIT Penn Medical Devices, Inc. FCL Class I 1987-10-14
K864963 STOMACH EVACULATOR - EWALD STYLE Medovations, Inc. KOA Class I 1987-10-14
K873177 DEVINE (SUPRAPUBIC SOUND AND GUIDE) Penn Medical Devices, Inc. KOE Class II 1987-10-14
K873948 MODIFIED RECTAL NOZZLE Colon Therapeutics KPL Class II 1987-10-14
K872824 P. URINE METER, 250CC Ni-Med, Inc. KNX Class II 1987-10-14
K872364 HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 Travenol Laboratories, S.A. FII Class II 1987-10-13
K872221 DIALY-NATE SET & DIALY-NATE CATHETER Gesco Intl., Inc. FKO Class II 1987-10-13
K871526 ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER Cox Family Laboratories, Inc. EXB Class I 1987-10-13
K873421 KAWASUMI A.V. FISTULA SET Kawasumi Laboratories Co., Ltd. FKQ Class II 1987-10-09
K872771 LOW PROFILE GASTROSTOMY Microvasive KNT Class II 1987-10-09
K873516 KAWASUMI BLOOD TUBING LINE Kawasumi Laboratories Co., Ltd. FJK Class II 1987-10-05
K872857 HOSPAL DIALYSATE FOR C.A.V.H.D. Delmed, Inc. KPO Class II 1987-10-05
K873435 LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET Level 1 Technologies, Inc. KOD Class II 1987-10-05
K873178 URETERAL BULB DILATORS Penn Medical Devices, Inc. EZN Class II 1987-09-30
K872652 UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM Travenol Laboratories, S.A. FKX Class II 1987-09-30
K872509 LINDEN STONE EXTRACTION BALLOON Hobbs Medical, Inc. FGE Class II 1987-09-22
K872458 AN3200 DOUBILET DRAIN H.W. Andersen Products, Inc. FGE Class II 1987-09-21
K871653 DURAPHASE PENILE PROSTHESIS Dacomed Corp. FAE Class II 1987-09-18
K872992 SPS SUSPENSION ENEMA KIT Carolina Medical Products Co. FCE Class I 1987-09-17
K872353 SURGITEK INFUSION STENT SYSTEM* Surgitek FAD Class II 1987-09-16
K872932 MOSS(R) MARK IV NASAL TUBES CAT.# 87168 Mfg. and Research, Inc. KNT Class II 1987-09-15
K872456 HEMOCOR PLUS HEMOCONCENTRATOR Minntech Corp. KDI Class II 1987-09-15
K873455 S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS Dravon Medical, Inc. FJK Class II 1987-09-14
K872282 FLEXIBLE URETEROSCOPE Intramed Laboratories, Inc. FGB Class II 1987-09-14
K873136 MMG CATH-N-PLACE Medical Technologies of Georgia KNX Class II 1987-09-09
K872531 MIC MUSHROOM TIP GASTROSTOMY TUBE Medical Innovations Corp. KNT Class II 1987-09-04
K872750 LAKE CATHETER CARE KIT Lake Medical Products, Inc. KOD Class II 1987-09-03
K872077 MODEL 1858 CAVRO/PRESSURE MODULE Life-Tech Intl., Inc. EXY Class II 1987-08-27
K871846 FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM Abbott Laboratories KNT Class II 1987-08-26

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