meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
44
Latest Decision
1994-11-22

Clearances · page 69 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K942544 GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS Medi-Globe Corp. LQC Class II 1994-11-22
K945369 LAPAROSCOPIC SURGICAL INSTRUMENTS FOR GENERAL USE Advanced Surgical, Inc. GCJ Class II 1994-11-22
K942445 SYNERGY II Synectics Medical, Inc. MMZ Class II 1994-11-22
K944054 POWDER FREE SURGEON'S GLOVE Arent Fox KGD Class II 1994-11-17
K944236 NEEDLELESS URINE SAMPLING PORT Kendall Healthcare Products Co. Div.Of Tyco Health KNX Class II 1994-11-16
K944292 SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE Surgical Innovations Corp. OCW Class II 1994-11-15
K944435 DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER Deroyal Industries, Inc. OCW Class II 1994-11-15
K943078 HOT BIOPSY FORCEPS Intl. Medical, Inc. KGE Class II 1994-11-14
K944821 MODEL 5151 Richard Wolf Medical Instruments Corp. GCT Class II 1994-11-14
K941348 KRONNER LAPAROSCOPIC HOLDER Kronner Prototypes, Inc. GCJ Class II 1994-11-14
K944081 OLYMPUS SWITCHING UNIT MODEL SU-1 Olympus America, Inc. FET Class II 1994-11-14
K945059 KARL STORZ SUCTION/IRRIGATION TUBES. CANNULAE, SHEATHS KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-11-09
K944955 AESCULAP THORACOSCOPIC INSTRUMENTS Aesculap, Inc. KNS Class II 1994-11-09
K945133 MODIFIED BIOPSY NEEDLE Biopsys Medical, Inc. FCG Class II 1994-11-09
K945101 KARL STORZ RETRACTORS, PROBES, DISSECTORS, HOOKD KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-11-09
K940960 SUCTION AND IRRIGATION TUBES Richard Wolf Medical Instruments Corp. GCJ Class II 1994-11-08
K944954 ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS United Fortune International, Inc. GCJ Class II 1994-11-08
K944974 ACCESS POINT Access Surgical Intl., Inc. GCJ Class II 1994-11-08
K943327 CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTS Conmedcorp GCJ Class II 1994-11-07
K943435 CHOLANGIOGRAPHY SET Karl Storz Endoskop GmbH GCJ Class II 1994-11-07
K943632 REPLACEMENT BATTERIES National Custom Ent., Inc. FCO Class I 1994-11-04
K945102 MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE Alm Surgical Equipment, Inc. FFS Class II 1994-11-04
K943680 NCE REPLACEMENT BATTERIES National Custom Ent., Inc. FCO Class I 1994-11-04
K945023 ORIGIN PIXIE STIC INTRODUCER SLEEVE Origin Medsystems, Inc. GCJ Class II 1994-11-04
K944959 AMPLATZ SUPER STIFF GUIDEWIRE Boston Scientific Corp OCY Class II 1994-11-04
K940790 BABCOCK/BOWEL CLAMP FORCEPS Richard Wolf Medical Instruments Corp. GCJ Class II 1994-11-03
K944870 JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680 J. Jamner Surgical Instruments, Inc. GCJ Class II 1994-11-02
K942301 MICROVASIVE INJECTION GOLD PROBE Boston Scientific Corp KNS Class II 1994-11-02
K942753 ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER Researched, Novel Medical Devices (Rn/Md) EYZ Class I 1994-11-02
K945204 URINE COLLECTOR & ACCESSORIES Nelmed Corp. FAQ Class I 1994-11-02
K944776 CLEAR BLUE ENDOSCOPIC LENS FOG RDUCTION SOLUTION & CLEANING KIT Blue Planet Industries, Inc. FEB Class II 1994-11-01
K943752 RIMECO MIDSTREAM URINE COLLECTOR Rimeco Products, Inc. FOC Class II 1994-11-01
K944688 LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR Progressive Dynamics, Inc. FFS Class II 1994-11-01
K941750 PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES Boston Scientific Corp FDI Class II 1994-11-01
K943685 MIC DISPOSABLE SNARE Medical Innovations Corp. KNT Class II 1994-11-01
K944418 THE SPACEMAKER AND THE SPACEMAKER II General Surgical Innovations GCJ Class II 1994-11-01
K940152 CAMERA COVER WITH TEAR TIP Hydro-Med Products, Inc. FEM Class I 1994-10-28
K941391 INFLATABLE RETENTION CUFF SPECULUM Innovatec Medical Corp. GBT Class II 1994-10-20
K922088 FRESENIUS DIALYSATE ACID CONCENTRATE Fresenius USA, Inc. KPO Class II 1994-10-17
K944837 MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE Medical Device Technologies, Inc. KNW Class II 1994-10-14
K944770 LSVP INTERNATIONAL BIOPSY FORCEPS Lsvp Intl., Inc. FCL Class I 1994-10-13
K934895 GLASSMAN SILICONE CATHETER Axiom Medical, Inc. EZL Class II 1994-10-13
K942110 INJECT-SNARE Endovations FDI Class II 1994-10-13
K934649 GALILEO ENDOSCOPES Galileo Electro-Optics Corp. FBO Class II 1994-10-13
K944782 CATCO UROLOGICAL CATHETER Catco Medical, Inc. EZD Class II 1994-10-13
K943253 INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P. Innerdyne Medical, Inc. GCJ Class II 1994-10-11
K944049 OXYGEN MOUTHGUARD Endovations, Inc. MNK Class I 1994-10-11
K944640 LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT Gabris Surgical Corp. FBQ Class II 1994-10-11
K944754 AMPLATZ SUPER STIFF GUIDEWIRE Boston Scientific Corp KNY Class II 1994-10-07
K943502 UNIGRIP Unisurge, Inc. GCJ Class II 1994-10-07
K935630 NORTA Beiersdorf, Inc. EZL Class II 1994-10-07
K926374 SILICONE CATHETER REPAIR KITS Akcess Medical Products, Inc. KOC Class II 1994-10-07
K941506 URETERAL ILLUMINATOR Apple Medical Corp. FCS Class II 1994-10-05
K944536 GSI KNOTMAKER General Surgical Innovations GCJ Class II 1994-10-05
K941715 ULTATHIN FLEXIBLE ENDOSCOPE Technology Marketing Group LYK Class II 1994-10-04
K944467 AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS Aesculap, Inc. GCJ Class II 1994-10-03
K942924 MSV-2000 VIDEO IMAGING SYSTEM Del Medical Systems Corp. GCJ Class II 1994-10-03
K923046 BIOLOGIC DT-1000 MACHINE Hemocleanse, Inc. KNT Class II 1994-09-30
K941958 WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE Western Dialysis Supplies , Ltd. KPO Class II 1994-09-30
K925405 ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. Synectics-Dantec FFT Class I 1994-09-30
K935633 NO-MES Ethox Corp. KNT Class II 1994-09-30
K926568 BAXTER CT DIALYZER Baxter Healthcare Corp KDI Class II 1994-09-30
K925522 CENTRYSYSTEM 3 WITH CHARTS/BP OPTION C.G.H. Medical, Inc. KOC Class II 1994-09-30
K923993 WALLSTENT BILIARY ENDOPROTHESES Schneider U.S. Stent Div. FGE Class II 1994-09-30
K943651 TECHNA-CUT ASPIRATION NEEDLE Manan Medical Products, Inc. KNW Class II 1994-09-29
K933842 KLEIN RECTAL TAMPNADE BALLOON Cook Urological, Inc. KNT Class II 1994-09-29
K934848 MASTER ALERT Master Hydro Systems, Inc. FIP Class II 1994-09-29
K930623 MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH Boston Scientific Corp FGE Class II 1994-09-28
K935198 GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS Lake Region Mfg., Inc. KNT Class II 1994-09-28
K926581 MIC TRANSGASTRIC JEJUNAL TUBE Medical Innovations Corp. KNT Class II 1994-09-28
K940283 KARL STORZ ENDOVISION UROCAM/HYSTEROCAM Medical Concepts, Inc. FET Class II 1994-09-28
K931963 SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE Sandhill Scientific, Inc. FFT Class I 1994-09-28
K942574 GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER Acufex Microsurgical, Inc. GCJ Class II 1994-09-28
K944465 CARRIER, LIGATURE (79 GEJ) Endotec, Inc. GCJ Class II 1994-09-28
K944414 DEKALB Endotec, Inc. GCJ Class II 1994-09-27
K943056 SINGLE STICK RADIALLY EXPANDING DILATOR Innerdyne Medical, Inc. GCJ Class II 1994-09-27
K941563 THE BIOPSY TOOL Citation Medical Corp. FCG Class II 1994-09-26
K944304 ORIGIN BALLOON ANCHOR Origin Medsystems, Inc. GCJ Class II 1994-09-23
K934610 CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS Tabex Industries, Inc. FJS Class II 1994-09-23
K942306 IRRIGATION/ASPIRATION INSTRUMENT Megadyne Medical Products, Inc. GCJ Class II 1994-09-23
K944135 UROLOGICAL GUIDWIRE Applied Medical Resources KNY Class II 1994-09-21
K943668 KSEA CONTINOUS FLOW CYSTOSCOPE KARL STORZ Endoscopy-America, Inc. FBO Class II 1994-09-21
K940983 THE KARL STORZ UROMAT(TM) KARL STORZ Endoscopy-America, Inc. LJH Class II 1994-09-20
K944249 AUTO SUTURE* ANTI-FOG DEVICE** United States Surgical, A Division of Tyco Healthc FEB Class II 1994-09-20
K944224 KARL STORZ FLUID LIGHT CABLES KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-09-20
K943927 END-O-FOG ENDOSCOPIC FOG ELIMINATION SYSTEM American Hydro-Surgical Instruments, Inc. GCJ Class II 1994-09-16
K935277 KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-09-16
K940206 BARD URINE COLLECTION PRODUCTS MODIFICATION C.R. Bard, Inc. KNX Class II 1994-09-16
K943697 TROCARS,CANNULAE,SHEATHS,OBTURATORS Karl Storz Endoskop GmbH ODB Class II 1994-09-14
K943786 PORTLAND TROCARS Mikroland Micromecanique GCJ Class II 1994-09-14
K940731 INNERVISION INC. CANNULA/TROCAR,MULTIPLE TYPES Innervision, Inc. GCJ Class II 1994-09-13
K944082 ASLAN DUAL ACTION JAWS GRASPING FORCEPS Aslan Medical Technologies, Ltd. GCJ Class II 1994-09-13
K944104 GABRIS LAPAROSCOPIC SURGICAL KITS Gabris Surgical Corp. FBQ Class II 1994-09-13
K944103 LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT Gabris Surgical Corp. GCJ Class II 1994-09-12
K941853 PASSPORT Boston Scientific Corp EZN Class II 1994-09-12
K922990 HEMODIALYSIS BATH Medi-Tech, Inc. KPO Class II 1994-09-12
K935279 KARL STORZ HOPKINS I RIGID AUTOCLAVABLE TELESCOPE, KARL STORZ HOPKINS II RIGID AUTOCLAVABLE TELESCOPE KARL STORZ Endoscopy-America, Inc. GCJ Class II 1994-09-12
K940594 KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE KARL STORZ Endoscopy-America, Inc. FGA Class II 1994-09-09
K934072 CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM Contour Fabricators of Florida, Inc. KNY Class II 1994-09-08
K942177 FOLEY CATHETERIZATION TRAY Customed, Inc. FCM Class II 1994-09-08

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