meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
28
Latest Decision
1994-05-24

Clearances · page 31 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K930955 CERVEX-BRUSH Rovers B.V. HHT Class II 1994-05-24
K940709 SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS Baxter Healthcare Corp HET Class II 1994-05-19
K922711 FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE Optimed Technologies, Inc. HIH Class II 1994-05-17
K924631 CABOT MEDICAL UTERINE RESECTOSCOPE Cabot Medical Corp. HIH Class II 1994-05-16
K941528 PEARL PACKING FORCEPS Cook Urological, Inc. HCZ Class II 1994-05-12
K935785 KARL STORZ IRRIGATION AND SUCTION SYSTEM HANDPIECE AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. HET Class II 1994-05-11
K921518 LIFETEK IUI CATHETER Lifetek Medical, Inc. MFD Class II 1994-05-10
K940462 HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION KARL STORZ Endoscopy-America, Inc. HET Class II 1994-05-10
K934114 KARL STORZ ELECTRONIC LAPAROFLATOR KARL STORZ Endoscopy-America, Inc. HIF Class II 1994-05-10
K934043 KARL STORZ ELECTRONIC LAPAROFLATOR KARL STORZ Endoscopy-America, Inc. HIF Class II 1994-05-10
K921727 CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575 Viggo-Spectramed KNF Class II 1994-05-10
K941094 INSUFFLATION TUBING & FILTER H & C Chemical, Inc. HET Class II 1994-05-10
K940049 KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS Baxter Healthcare Corp HET Class II 1994-05-06
K934011 MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE Neward Enterprises, Inc. HDB Class II 1994-05-04
K930132 LEEP AND LLETZ ELECTRODES Nordex Medical Corp. HGI Class II 1994-05-04
K925738 WHITE RIVER MANUAL BREAST PUMP White River (Tm) HGY Class I 1994-05-04
K912325 MICRO-PAP(TM) KIT Micro-Pap Corp. HHT Class II 1994-05-02
K940844 MYOMA DRILL 5MM-8383.611 Richard Wolf Medical Instruments Corp. HET Class II 1994-05-02
K935697 CIRCUMCISION TRAY Cush Medical Products HFX Class II 1994-05-02
K921722 BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA Bard Reproductive Systems HET Class II 1994-05-02
K925968 ENDOSCOPE United States Surgical, A Division of Tyco Healthc HET Class II 1994-04-28
K935822 PHASE I CURETTE Phase I Corp. HCY Class I 1994-04-28
K935031 RIZA-RIBE NEEDLE R-Med, Inc. HET Class II 1994-04-25
K931654 BIRTCHER MAGNETIC RETRIEVER (GS-3100) Birtcher Medical Systems, Inc. HET Class II 1994-04-25
K931771 BIRTCHER ENDOSCOPIC CORKSCREW Birtcher Medical Systems, Inc. HET Class II 1994-04-25
K922911 OPTIONS COMFORT CURVES CLOTH MENSTRUAL PAD SYSTEM Feminine Options HHD Class I 1994-04-22
K941494 ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS Sharpe Endosurgical Corp. HET Class II 1994-04-22
K922154 INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION Olsen Electrosurgical, Inc. HIB Class II 1994-04-21
K932456 JARIT SURGICAL INSTRUMENTS J. Jamner Surgical Instruments, Inc. KNF Class II 1994-04-21
K930696 SURE-FLO INSUFFLATION TUBING O.R. Resources, Inc. HIF Class II 1994-04-19
K931630 INSEMI-CATH Cook Ob/Gyn MFD Class II 1994-04-19
K932216 C-SECTION, LABOR & DELIVERY TRAYS (PACKS) Associated Medical Products Co. MLS Class II 1994-04-19
K941196 PLATEX TAMPONS MODEL NUMBER 07094 Playtex Family Products, Inc. HIL Class II 1994-04-19
K930767 INSUFO-GARD #100-104 Acorn Medical, Inc. HIF Class II 1994-04-18
K933094 INSUFFLATOR TUBING KIT W/FILTER Inman Medical Corp. HIF Class II 1994-04-18
K935562 PANTY LINERS Lady'S Care, Inc. HHD Class I 1994-04-13
K940329 NATRACARE MENSTRUAL PADS Natracare, LLC HHD Class I 1994-04-13
K933950 LADY'S CARE MAXI PADS Lady'S Care, Inc. HHD Class I 1994-04-13
K932432 KRONNER REINFORCING STYLETTE Unimar, Inc. LKF Class II 1994-04-12
K932689 LAPRO-LOADER(TM) Surgimark, Inc. HET Class II 1994-04-11
K923259 LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS Imtec Corp. HET Class II 1994-04-11
K936155 ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA Micromedical Devices, Inc. HIF Class II 1994-04-11
K926021 NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE Zinnanti Surgical Instruments, Inc. HET Class II 1994-04-07
K932077 MODEL 151 FETAL MONITOR Ge Medical Systems Information Technologies HGM Class II 1994-03-31
K936120 LABOR AND DELIVERY TRAY Cush Medical Products MLS Class II 1994-03-30
K921686 ENDOMED LAPAROSCOPY INSTRUMENTS Buckman Co., Inc. KNF Class II 1994-03-30
K921756 ELECTRONIC INSUFFLATOR MODEL 2054.61 Richard Wolf Medical Instruments Corp. HIF Class II 1994-03-28
K940377 UNSCENTED MENSTRUAL PAD TIER-1 REVIEW Eldari, Ltd. HHD Class I 1994-03-25
K926179 SEDLACEK HANDLE Simpson/Basye, Inc. HGI Class II 1994-03-25
K922632 WOM HYSTEROFLATOR OP W.O.M. GmbH HIG Class II 1994-03-25
K921405 DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP Davol, Inc. HFG Class II 1994-03-25
K935636 GRAVESPEC Adept-Med Intl., Inc. HIB Class II 1994-03-25
K933492 ESYS SYSTEM Endolap, Inc. HET Class II 1994-03-25
K940821 PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED Playtex Family Products, Inc. HIL Class II 1994-03-25
K921885 E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES Valleylab, Inc. HGZ Class II 1994-03-25
K933879 PADS MENSTRUAL, UNTREAT DEODORIZED, VARIOUS SIZES Universal Health Care Products Canada, Inc. HHD Class I 1994-03-24
K932782 HM-0660 Hill-Med, Inc. HEX Class II 1994-03-23
K932896 HM-0690 COLPOSCOPE Hill-Med, Inc. HEX Class II 1994-03-23
K931722 CARAPACE LABOR AND DELIVERY SETS Carapace, Inc. MLS Class II 1994-03-23
K922777 PRESSURE TUBING AND ACCESSORIES Arbor Technologies, Inc. HIF Class II 1994-03-22
K924481 INSUFFLATION TUBING Applied Medical Resources HIF Class II 1994-03-22
K934506 DYNABITE HYSTEROSCOPIC FORCEPS Portlyn Corp. HET Class II 1994-03-22
K932118 ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET Core Dynamics, Inc. HET Class II 1994-03-17
K935639 INSUFFLATION TUBING STERILE AND NON-STERILE Charles Polo & Co., Inc. HIF Class II 1994-03-17
K933698 100 SERIES ENDOSCOPIC GRASPING FORCEPS Cook Urological, Inc. HET Class II 1994-03-17
K934451 HASSON 360 SERIES ENDOSCOPIC GRASPING FORCEPS Cook Urological, Inc. HET Class II 1994-03-17
K933130 TROGARD TROCAR SLEEVE RETAINING THREAD Conmedcorp HET Class II 1994-03-17
K931205 MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER Baxter Healthcare Corp HHI Class II 1994-03-15
K930400 TERRA FEMME Bio Business Intl, Inc. HEB Class II 1994-03-14
K915857 FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE Olympus Corp. HET Class II 1994-03-11
K936026 COOK LAPAROSCOPIC MINI RETRACTOR SET Cook Urological, Inc. HFI Class II 1994-03-11
K933008 RETRACTORS AND SCRAPER Baxter Healthcare Corp HET Class II 1994-03-11
K930934 ENDOPATH RELOADABLE LINEAR CUTTER ETHICON, Inc. HET Class II 1994-03-11
K933628 CYTOLOGY BRUSH Bioteque America, Inc. HHT Class II 1994-03-11
K924485 LAPAROSCOPY SET Owens Precision Systems, Inc. HET Class II 1994-03-09
K930756 LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE Endo Technic Corp. HET Class II 1994-03-09
K936189 PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED Playtex Family Products, Inc. HIL Class II 1994-03-07
K926425 AMNIPERF(TM) Raymart Development Co. HGE Class I 1994-03-07
K934083 PLAYTEX ULTIMATES TAMPONS Playtex Family Products, Inc. HIL Class II 1994-03-07
K935276 PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS Playtex Family Products, Inc. HIL Class II 1994-03-07
K934131 DEROYAL SURGICAL DISPOSABLE INSUFFLATION TUBING Deroyal Industries, Inc. HIF Class II 1994-03-07
K935503 DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET Davol, Inc. HIF Class II 1994-03-07
K933521 SPECULUM Bioteque America, Inc. HIB Class II 1994-03-07
K931822 CARAPACE PELVIC EXAM TRAYS Carapace, Inc. MLT Class II 1994-03-07
K932909 PLAYTEX ULTIMATES TAMPONS Playtex Family Products, Inc. HIL Class II 1994-03-07
K932907 PLAYTEX ULTIMATES TAMPONS Playtex Family Products, Inc. HIL Class II 1994-03-07
K925558 INFILTUBE Medsurg Industries, Inc. HIF Class II 1994-03-04
K930149 KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+ Kimberly-Clark Corp. HEB Class II 1994-03-02
K930192 VCI INSUFLATOR FILTER W/ TUBING Vital Concepts, Inc. HIF Class II 1994-03-02
K924148 DIAMOND-SHARP(R) TROCARS Snowden-Pencer HFI Class II 1994-02-28
K926429 VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT Thomasville Medical Assoc. HDF Class I 1994-02-28
K925114 LAPAROSCOPIC INSTRUMENTS Endo Technic Corp. HFI Class II 1994-02-28
K935947 HI-TOPS ELECTRODES 14-8000 W. J. Medical Instruments, Inc. KNF Class II 1994-02-28
K923570 CRYOMEDICS LLETZ LOOPS Cabot Medical Corp. HGI Class II 1994-02-28
K926484 CORSON MYOMA GRASPING FORCEPS Thomasville Medical Assoc. HCZ Class II 1994-02-25
K926531 HYSTERECTOMY FORCEPS Thomasville Medical Assoc. HCZ Class II 1994-02-25
K932634 NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES Marlo Surgical Technology HET Class II 1994-02-25
K932832 PRIMUS INSULATED FORCEPS Marlo Surgical Technology HET Class II 1994-02-25
K933415 DETECT (TM) CYTOLOGY BRUSH Cook Ob/Gyn HHT Class II 1994-02-25
K926533 Z-CLAMP FORCEPS Thomasville Medical Assoc. HCZ Class II 1994-02-25

4,626 clearances in the Obstetrics/Gynecology panel. Data: openFDA.