meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
30
Latest Decision
1983-04-06

Clearances · page 103 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K830629 COBE RX METER Cobe Laboratories, Inc. FLB Class II 1983-04-06
K830905 LUNDIA 10-2-N PARALLEL FLOW DIALYZER Gambro, Inc. KOC Class II 1983-04-06
K830575 RENALIN (TENTATIVE Renal Systems, Inc. LIF Class II 1983-03-31
K830291 WAK WEARABLE ARTIFICIAL KIDNEY Wak-Utah KOC Class II 1983-03-29
K830729 C-DAK ARTIFICIAL KIDNEY Cordis Corp. KOC Class II 1983-03-29
K830574 RENATRON DIALYZER REPROCESSING SYS Renal Systems, Inc. LIF Class II 1983-03-29
K830710 ARGYLE SILICONE SALEM SUMP TUBE Sherwood Medical Co. KNT Class II 1983-03-29
K830647 H1210 Hospal Medical Corp. KDI Class II 1983-03-29
K823839 AMPCO KIDNEY DIALYSIS TRAY Associated Medical Products Co. KOC Class II 1983-03-29
K830766 ABBOTT PATIENT ASSIST DEVICE Abbott Laboratories FKX Class II 1983-03-29
K830648 H1207 Hospal Medical Corp. KDI Class II 1983-03-29
K830689 EMPTY DIALYSATE CONTAINER BB-69 Delmed, Inc. FKX Class II 1983-03-29
K823581 ELPHA 500 Prothia USA, Inc. GCJ Class II 1983-03-24
K830586 TRI-DILS-TRIPLE OLIVE-ESOPHAGEAL DILATOR Keymed, Inc. KNQ Class II 1983-03-24
K830183 ASAHI HOLLOW FIBER KIDNEYS NR SERIES Advocacy International, Ltd. KOC Class II 1983-03-17
K830231 ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES Advocacy International, Ltd. KOC Class II 1983-03-17
K830438 MCDLSCK 126 DOUBLE LUMEN SUBCLAVIAN-FEM Medcomp LFJ Class II 1983-03-17
K830359 STERILE CATHERIZATION PROCEDURE TRAYS Welcon, Inc. KOD Class II 1983-03-17
K823827 AMP 80/2 OUTFLOW MONITOR MODIFICATION American Medical Products, Inc. FKX Class II 1983-03-17
K830247 SPLIT COLON STIFFENING TUBE Keymed, Inc. FED Class II 1983-03-15
K830002 CAPD COLOR-GUARD SYSTEM PREPKIT Abbott Laboratories FKY Class II 1983-03-11
K830444 STERILE, ALL PURPOSE URETHRAL CATHETER Abco Dealers, Inc. KOD Class II 1983-03-09
K830483 COONS SOFT STENT Medi-Tech, Inc. FGE Class II 1983-03-09
K830208 BETA-CAP D ADAPTER Quinton, Inc. FKX Class II 1983-03-07
K823135 DOUBLE LUMEN SUBCLAVIAN CATHETER Abbott Laboratories LFJ Class II 1983-03-07
K830284 FH 101, FH 202 & FH 303 FIBER HEMOFILTER Gambro, Inc. KDI Class II 1983-03-02
K830257 NON-STERILE PERITONEAL ACCESS CATHET- Evermed, Inc. FKX Class II 1983-02-24
K822339 KF-101-13 DIALYZER Extracorporeal Medical Specialities, Inc. KOC Class II 1983-02-16
K822338 KF-101-10 DIALYZER Extracorporeal Medical Specialities, Inc. KOC Class II 1983-02-16
K822337 KF-101-07 DIALYZER Extracorporeal Medical Specialities, Inc. KOC Class II 1983-02-16
K823701 MOTILITY CATHETERS Mui Scientific FFX Class II 1983-02-15
K830086 4.5 F LITHOTRIPTOR ELECTRODE Monaghan Medical Corp. FFK Class II 1983-02-09
K823715 SINGLE ACCESS DEVICE (SSAD) Samaritan Hospital KOC Class II 1983-02-07
K830192 MAC LEE UI URINE COLLECTION BAG Mac Lee Medical Products KNX Class II 1983-02-01
K830119 NEEDLE CATHETER JEJUNOSTOMY KIT Biosearch Medical Products, Inc. KNT Class II 1983-01-28
K823390 PC 201A LOCKING SLEEVE Medigroup FKX Class II 1983-01-26
K823857 IMPRA PERITONEAL CATHETER Impra, Inc. FKX Class II 1983-01-26
K823330 DIALATORS PC-203 & 202 Medigroup FKX Class II 1983-01-26
K823296 PC-205 TENCKHOFF CATHETER ROD OBTURATOR Medigroup FKX Class II 1983-01-26
K823068 MEDISYSTEMS FISTULA NEEDLES Medisystems Corp. KOC Class II 1983-01-26
K823331 PC-204 TUNNELOR Medigroup FKX Class II 1983-01-26
K823303 QUILL CATHETER GUIDE Medigroup FKX Class II 1983-01-26
K823069 KF-E SERIES HOLLOW FIBER DIALYZER Medisystems Corp. KOC Class II 1983-01-21
K823428 KELLY INFLATABLE T DRAIN Akron Catheter, Inc. FGE Class II 1983-01-18
K823779 DIALYTE Renal Dynamics, Inc. KPO Class II 1983-01-17
K823881 ARTERIOVENOUS BLOOD TUBING SET FOR Amicon, Inc. KDI Class II 1983-01-17
K830021 A.V. FISTULA CANNULATION SETS Travenol Laboratories, S.A. KOC Class II 1983-01-14
K823716 CYSTOFLO URINARY DRAINAGE BAG W/ANTIMIC Travenol Laboratories, S.A. KNX Class II 1983-01-14
K830026 FIBERSCOPE DISINFECTANT IRRIGATOR Keymed, Inc. FEB Class II 1983-01-14
K823733 EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR Advocacy International, Ltd. KOC Class II 1983-01-14
K823752 EXTRACORPOREAL SUBCLAVIAN CATHETER KIT Extracorporeal Medical Specialities, Inc. FIQ Class II 1983-01-14
K823791 LUNDIA 10-5-L PARRALLE FLOW DIALYZER Gambro, Inc. KOC Class II 1983-01-12
K823826 CAPILLARY FLOW DIALYZERS Travenol Laboratories, S.A. KOC Class II 1983-01-12
K823818 CATHETER HOLDER Danek Medical, Inc. KOD Class II 1983-01-09
K823561 URETHRAL PRESSURE PROFILE & TEMP. MODUL Nihon Kohden America, Inc. FAP Class II 1983-01-07
K823778 GAMMA STERILIZED CAPILLARY FLOW DIALYZ Travenol Laboratories, S.A. KOC Class II 1983-01-07
K823338 COBE HEMOCONCENTRATOR 1.3 Cobe Laboratories, Inc. KDI Class II 1983-01-07
K823777 STERILE, DISPOS. SPIKE PROTECTOR-5C4138 Travenol Laboratories, S.A. FKX Class II 1983-01-07
K823707 HOSPAL BLOOD LINES Hospal Medical Corp. KOC Class II 1983-01-05
K823450 FEMALE EXTERNAL URINARY APPLIANCE Diamed Division Ill. Tool Works, Inc. KNX Class II 1982-12-28
K823411 PEDIATRIC URINE COLLECTOR Sage Products, Inc. KNX Class II 1982-12-28
K823589 H 12 07 Hospal Medical Corp. KDI Class II 1982-12-22
K823546 RENAFLO II Renal Systems, Inc. KOC Class II 1982-12-16
K823288 AMICON DIAFILTERS 20 & 30 HEMOFILTERS Amicon, Inc. KDI Class II 1982-12-16
K822916 UROCOMP REMOTE CONTROL 1804 Life-Tech Intl., Inc. FAP Class II 1982-12-13
K823375 NEPHROSS, ANDANTE H.F. Organon Teknika Corp. KOC Class II 1982-12-07
K823274 UNI-TIP COLOSTOMY IRRIGATION CONE Howmedica Corp. EXD Class II 1982-12-07
K823195 GASTRIC LAVAGE KIT Autovage KNT Class II 1982-12-03
K822964 RIGHT ATRIAL CATHETER Quinton, Inc. LFJ Class II 1982-11-30
K823217 INPERSOL PERITONEAL DIALSIS CYCLER SET Abbott Laboratories FKX Class II 1982-11-30
K823432 1512M/F WIRE ELECTRODE NEEDLE SET Life-Tech Intl., Inc. FAP Class II 1982-11-30
K822910 RIGHT ARTERIAL CATHETER Quinton, Inc. LFJ Class II 1982-11-29
K823276 BED GUARD T. S. Enterprises, Inc. KPN Class II 1982-11-24
K823092 HEMAFLO BLOOD TUBING SETS Cobe Laboratories, Inc. FKQ Class II 1982-11-22
K822765 SIGMOIDOSCOPE, FLEXIBLE Harvard Laboratories FAM Class II 1982-11-17
K823103 DIALYSATE ADDITIVES-POWDER/LIQUID Di-Chem, Inc. KPO Class II 1982-11-17
K822087 DIA SCOPE Exitec, Inc. KNT Class II 1982-11-17
K822879 ENTERAL NUTRITION 1 Exco, Inc. KNT Class II 1982-11-16
K823082 TRAVASORB NASOGASTRIC NASOINTESTINAL Travenol Laboratories, S.A. KNT Class II 1982-11-16
K822711 ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL Parker Laboratories, Inc. FAX Class I 1982-11-03
K822340 EXTRACORPOREAL SINGLE NEEDLE MODULE Extracorporeal Medical Specialities, Inc. KOC Class II 1982-11-03
K822846 PENTAX FC-38LA & FC-38SA COLONOFIBER Pentax Precision Instrument Corp. FDF Class II 1982-10-22
K822959 ENDOSCOPIC VIDEOSYSTEM Eder Instrument Co, Inc. FET Class II 1982-10-22
K822815 MODEL 700 GASTROREFLUX MONITOR/AMALYZER Del Mar Avionics FFT Class I 1982-10-22
K822712 INPERSOL-CAPD ADMINIS. SET TYPE DP Abbott Laboratories FKX Class II 1982-10-21
K822658 EXTENSION SET TYPE DP Abbott Laboratories FKX Class II 1982-10-21
K822004 FACE SHIELDS Kelleher Corp. KNT Class II 1982-10-20
K822796 NEGATIVE PRESSURE ARTERIAL BLOOD LINE Erika, Inc. KOC Class II 1982-10-18
K821863 DIALYZER REPROCESSING SYSTEM DRS-4 Seratronics, Inc. LIF Class II 1982-10-18
K822880 ARTERIO VENOUS SHUNT CANNULA & ADAPTORS Renal Systems, Inc. FIQ Class II 1982-10-18
K822544 SAFE LOCK SEALING CAP L American Medical Products, Inc. FKX Class II 1982-10-13
K822549 CCPD CYCLER SET W/5 PRONGED SAFE LOCK American Medical Products, Inc. FKX Class II 1982-10-13
K822545 CCPD CYCLER SET W/5 PRONGED CONNECTOR American Medical Products, Inc. FKX Class II 1982-10-13
K822550 SAFE LOCK TITANIUM ADAPTER SET American Medical Products, Inc. FKX Class II 1982-10-13
K822385 EXTRAPURE REVERSE OSMOSIS WATER UNIT Extracorporeal Medical Specialities, Inc. FIP Class II 1982-10-13
K822548 SAFE LOCK CATHETER S-3 American Medical Products, Inc. FKX Class II 1982-10-13
K822551 AMP CAPD UNISPIKE AMINISTRATION SET American Medical Products, Inc. FKK Class I 1982-10-13
K822875 PEDI-TUBE PEDIATRIC FEEDING TUBE Biosearch Medical Products, Inc. KNT Class II 1982-10-13
K822543 CAPD SAFE LOCK TRANSFER SET American Medical Products, Inc. FKX Class II 1982-10-13
K822546 SAFE LOCK SEALING CAPS American Medical Products, Inc. FKX Class II 1982-10-13

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