meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
31
Latest Decision
1993-09-28

Clearances · page 75 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K931025 INTHERM STASIS VALVE SYSTEM Interventional Therapeutics Corp. FGE Class II 1993-09-28
K932142 SUCTION GUILLOTINE DEVICE Triton Technology, Inc. FCK Class II 1993-09-24
K930758 DIAGNOSTIC INTRAVASCULAR CATHETER Applied Medical Resources LYK Class II 1993-09-24
K933604 QB II BLUNT DISSECTOR Joyce M. Shotwell, M.D. FGS Class II 1993-09-23
K932995 SURGICAL TROCAR AND CANNULA Applied Medical Resources GCJ Class II 1993-09-23
K923201 ENDOSI SUCTION IRRIGATOR Armm, Inc. GCJ Class II 1993-09-23
K932045 DISPOSABLE INSUFFLATION TUBING L.A.S.E.R., Inc. GCJ Class II 1993-09-23
K924714 BARD URODYNAMIC CATHETER C.R. Bard, Inc. FEN Class II 1993-09-21
K925659 U.C.E.Z. LENS CLEANER KIT Anago, Inc. OCT Class II 1993-09-17
K931282 VOLUME TRANSDUCER Life-Tech Intl., Inc. EXQ Class II 1993-09-17
K932300 FOG CONTROL, LENS FOG REDUCTION DEVICE Highpoint Medical Corp. OCT Class II 1993-09-17
K933104 ONE-HANDED ENDOPOUCH SPECIMEN RETRIEVAL BAG ETHICON, Inc. GCJ Class II 1993-09-13
K933201 AESCULAP TROCAR INSTRUMENT SET Aesculap, Inc. GCS Class II 1993-09-13
K933076 AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS Aesculap, Inc. GCJ Class II 1993-09-10
K933216 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ Endoscopy-America, Inc. FFS Class II 1993-09-09
K933032 LAPAROSCOPIC SURGICAL RETRACTOR Advanced Surgical, Inc. GCJ Class II 1993-09-09
K921103 RETRACTION INSTRUMENT Origin Medsystems, Inc. GCJ Class II 1993-09-09
K932976 CABOT MEDICAL OPTIMA HAND INSTRUMENTS Cabot Medical Corp. GCJ Class II 1993-09-07
K930463 LOCKING PIVOTAL THORACOPORT Surgical Technologies, Inc. GCJ Class II 1993-09-07
K931138 CORE DYNAMICS LAPAROSCIPIC IRRIGATION PUMP Core Dynamics, Inc. GCJ Class II 1993-09-07
K932977 CABOT MEDICAL OPTIMA HAND INSTRUMENTS Cabot Medical Corp. GCJ Class II 1993-09-07
K931895 ENDOSCOPE ACCESSORY Applied Medical Resources GCJ Class II 1993-09-07
K925382 CUTTER, SURGICAL Mectra Laboratories, Inc. GCJ Class II 1993-09-03
K933009 SURGICAL RETRACTOR/BLUNT DISSECTOR Advanced Surgical, Inc. GCJ Class II 1993-09-03
K930348 COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM Boston Scientific Corp FDX Class II 1993-09-03
K923755 FLEX FINDER GUIDEWIRE Flex Medics Corporation OCY Class II 1993-09-03
K932762 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT Inman Medical Corp. GCS Class II 1993-08-31
K924697 FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT Abbott Laboratories KNT Class II 1993-08-27
K931896 PRO-FLO SYSTEM Lafayette Pharmacal, Inc. FCE Class I 1993-08-26
K933661 INSUFFLATOR TUBING KIT W/FILTER Eagle Medical, Inc. GCJ Class II 1993-08-25
K933520 ENDOSCOPIC ANTI-FOG KIT, 100-302-00 Avail-Southwest Division GCJ Class II 1993-08-24
K933049 SRUGICAL RETRACTOR, MODIFICATION Advanced Surgical, Inc. GCJ Class II 1993-08-24
K931115 HATCHER STONE-EMBOLIS EXTRACTOR Ideal Medical, Inc. LQR Class II 1993-08-20
K931619 MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER Boston Scientific Corp GCA Class II 1993-08-20
K931878 JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680 J. Jamner Surgical Instruments, Inc. GCJ Class II 1993-08-19
K925128 THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE KARL STORZ Endoscopy-America, Inc. FGB Class II 1993-08-18
K931518 IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE Imagyn Medical, Inc. GCJ Class II 1993-08-18
K932229 SURGICAL TROCAR AND TROCAR SLEEVE Origin Medsystems, Inc. GCJ Class II 1993-08-18
K921918 FIBER OPTIC ENDOSCOPE Electro Fiberoptics Corp. GCM Class II 1993-08-17
K932804 IRRIGATING TAPERED PROBE Mayaguez Medical Center GCJ Class II 1993-08-16
K930499 GRASPING FORCEPS FLEXIBLE STONE DISLODGER Endomedix OCZ Class II 1993-08-16
K932805 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT Mayaguez Medical Center GCJ Class II 1993-08-16
K926514 ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20 Olympus Corp. ODG Class II 1993-08-16
K930617 OBGRIP AND UNITIPS(TM) Unisurge, Inc. GCJ Class II 1993-08-11
K932806 POOLE TIP SUCTION PROBE & TUBING KIT Mayaguez Medical Center GCJ Class II 1993-08-11
K932449 DR. FOG O.R. Concepts, Inc. OCT Class II 1993-08-11
K931273 MIST FORCEPS/CLAMPS FOR LAPAROSCOPOIC/ENDOSCOPIC Minimally Invasive Surgical Technologies, Inc. GCJ Class II 1993-08-11
K933416 DEVMED LAP WASH REUSABLE ENDOSCOPIC LENS WASH SHEATH Devmed Corp. GCJ Class II 1993-08-10
K932604 UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC Unisurge, Inc. GCJ Class II 1993-08-10
K930809 UNITIPS Unisurge, Inc. GCJ Class II 1993-08-10
K931854 ENDOSCOPIC BLUNT DISSECTING INSTRUMENT Mayaguez Medical Center FGS Class II 1993-08-10
K925882 UNITIPS SURGICAL INSTRUMENTS Unisurge, Inc. GCJ Class II 1993-08-10
K925917 UNICHANNEL(TM SURGICAL GRASPER Unisurge, Inc. GCJ Class II 1993-08-10
K932265 SYMBIOSIS DISPOS PULMON BIOPSY FORCEPS W/REUS HAND Symbiosis Corp. FCL Class I 1993-08-09
K931013 FOLEY CATHETER TRAY Kit Pak, Inc. KNY Class II 1993-08-09
K932466 MEDCHEM SURGICAL DELIVERY SYSTEM Medco Products, Co., Inc. GCJ Class II 1993-08-09
K932281 VERRES NEEDLE Surgeon Surgical Instrumentation, Inc. GCT Class II 1993-08-06
K931262 REUSABLE/INTERCHANGEABLE SHAFT, ENDOSCOPIC SCISSOR T. Korossurgical Instruments Corp. GCJ Class II 1993-08-06
K931706 ENDOSCOPIC CABLE DRAPE Mayaguez Medical Center GCJ Class II 1993-08-06
K931649 LAPAROSCOPIC BALLOON RETRACTOR Cabot Medical Corp. GCJ Class II 1993-08-06
K931707 ENDOSCOPIC CABLE/WIRE COVER Mayaguez Medical Center GCJ Class II 1993-08-06
K926583 REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR T. Korossurgical Instruments Corp. GCJ Class II 1993-08-06
K933371 IMC ENDOSCOPIC INSTRUMENT HOLDER Inman Medical Corp. GCS Class II 1993-08-06
K926039 GUIDE-TECH ENCAPSULATED GUIDEWIRE Cape Tech Medical Products KNY Class II 1993-08-05
K931574 ADVANCE MODEL UDS-ADV Laborie Medical Technologies, Ltd. EXQ Class II 1993-08-05
K931275 MIST MICROSURGICAL MONOPOLAR FORCEPS Minimally Invasive Surgical Technologies, Inc. GCJ Class II 1993-08-05
K931274 MIST MICROSURGICAL MONOPOLAR SCISSORS Minimally Invasive Surgical Technologies, Inc. GCJ Class II 1993-08-05
K925396 PULSE GUARD ELECTRODE Northgate Technologies, Inc. FFK Class II 1993-07-30
K924372 LAPAROSCOPIC NERVE HOOK Nusurg, Inc. GCJ Class II 1993-07-30
K924308 GASTROPORT II Sandoz Nutrition KNT Class II 1993-07-29
K925599 FUJINON VIDEO LAPAROSCOPE-ADDITIONAL INTENDED USE Fujinon, Inc. GCJ Class II 1993-07-28
K932022 ENTREE THORACOSCOPY CANNULA SET Core Dynamics, Inc. GCJ Class II 1993-07-28
K930817 LAPAROSCOPIC LYMPHADENECTOMY Fujinon, Inc. GCJ Class II 1993-07-28
K931223 FUJINON VIDEO LAPAROSCOPE--THORACOSCOPY Fujinon, Inc. GCJ Class II 1993-07-28
K931898 ENDOSWAB Medline Industries, Inc. GCJ Class II 1993-07-28
K930474 NEEDLE, PNEUMOPERITONEUM, SPRING LOADED Ranfac, Corp. FHO Class II 1993-07-23
K931281 MICRO ENDOSCOPIC ELECTRODE (ME2) Codman & Shurtleff, Inc. GCJ Class II 1993-07-23
K931278 INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR Interventional Therapeutics Corp. GCJ Class II 1993-07-23
K931995 RESECTOSCOPE SHEATH Olympus Corp. FJL Class II 1993-07-23
K926089 KENSEY NASH WUIK-SERT(TM) ENDOSCOPIC SURG GRASPER Kensey Nash Corp. GCJ Class II 1993-07-23
K930716 LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION Gabris Surgical Corp. GCJ Class II 1993-07-23
K930572 NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM II PUMP American Hydro-Surgical Instruments, Inc. GCJ Class II 1993-07-23
K930733 URETERAL STENT Surgitek FAD Class II 1993-07-23
K931727 URINARY DRAINAGE BAG CADDY Neotech Products, Inc. FAQ Class I 1993-07-23
K931705 ENDOSCOPIC INSTRUMENT HOLDER Mayaguez Medical Center GCJ Class II 1993-07-22
K925624 MICROSURGICAL INSTRUMENTS Mahe-Medizintechnik GCJ Class II 1993-07-22
K930462 ENDOSCOPIC UMBRELLA RETRACTOR Surgical Technologies, Inc. GCJ Class II 1993-07-22
K925161 NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO North American Sterilization & Packaging Co. KNY Class II 1993-07-21
K922476 URO-PRO 2000 Fiberoptic Sensor Technlogies, Inc. FAP Class II 1993-07-20
K922776 FST COUNCIL TIP FOLEY CATHETER Fiberoptic Sensor Technlogies, Inc. FEN Class II 1993-07-20
K930483 URETERAL CATHETER Surgitek EYB Class II 1993-07-16
K921853 4 SURE TM FEEDING TUBES Boston Pacific Medical, Inc. KNT Class II 1993-07-13
K923096 URESIL BILLIARY CATHETER Uresil Corp. FGE Class II 1993-07-13
K930301 TROCAR SHEATH ANCHOR Origin Medsystems, Inc. GCJ Class II 1993-07-09
K930608 ONIK-COHEN ACCESS SET Cook Urological, Inc. KOD Class II 1993-07-09
K924011 ORIGIN BLUNT TIP SURGICAL TROCAR Origin Medsystems, Inc. GCJ Class II 1993-07-09
K930882 UROLOGICAL CATHETER & ACCESSORIES Applied Medical Resources FAD Class II 1993-07-08
K926110 ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT Advanced Surgical Intervention, Inc. GCJ Class II 1993-07-08
K925602 DAVIS+GECK ABSORBABLE LIGATING DEVICE Davis & Geck, Inc. GCJ Class II 1993-07-08
K924897 XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 Medical Devices, Inc. GCT Class II 1993-07-06

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