meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
39
Latest Decision
1998-06-23

Clearances · page 25 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K980814 PURESPERM Nidacon International AB MQL Class II 1998-06-23
K981621 ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS Suretex Prophylactics (India) , Ltd. LTZ Class II 1998-06-19
K980972 RIGID CULDOSCOPE AND ACCESSORIES Circon Corp. HEW Class II 1998-06-12
K980717 UROMED SLING KIT Uromed Corp. KNA Class II 1998-05-22
K970968 BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS Guenter Bissinger Medizintechnik GmbH HET Class II 1998-05-21
K980319 DUREX ULTRA COMFORT London Intl., LLC HIS Class II 1998-05-20
K971374 GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE Wilson Greatbatch Technologies, Inc. HIH Class II 1998-05-13
K980694 KSEA PLASTIC TROCARS KARL STORZ Endoscopy-America, Inc. HET Class II 1998-05-08
K980096 OAC (OPTICAL ASPIRATING CURETTE) Imagyn Medical Technologies, Inc. HCY Class I 1998-05-01
K974115 PELVX RING, PELVX RING WITH SUPPORT Deschutes Medical Products, Inc. HHW Class II 1998-04-27
K974117 PELVX DONUT, PELVX CUBE Deschutes Medical Products, Inc. HHW Class II 1998-04-27
K974116 PELVX INCONTINENCE RING Deschutes Medical Products, Inc. HHW Class II 1998-04-27
K980204 DUREX LATEX CONDOMS London Intl., LLC HIS Class II 1998-04-17
K980356 CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010 Canadian Medical Brush, Inc. HHT Class II 1998-04-16
K980395 GLADRAGS COTTON MENSTRUAL PAD Keepers!, Inc. HHD Class I 1998-04-16
K980134 KSEA N2O ENDOFLATOR KARL STORZ Endoscopy-America, Inc. HIF Class II 1998-04-15
K972647 CO2 PNEUMO-DISSECTOR Cook Urological, Inc. HET Class II 1998-04-10
K970961 VAPORIZATION ELECTRODES Richard Wolf Medical Instruments Corp. KNF Class II 1998-04-10
K980237 GYNEX ENDOSPECULUM Gynex Corp. KNA Class II 1998-04-08
K980478 PLAYTEX TAMPONS #03498 Playtex, Inc. HEB Class II 1998-04-03
K980166 LIGHTSOURCE OR ILLUMINATOR Cuda Products Co. HET Class II 1998-04-01
K980019 HTL MALE CONDOM Reddy Medtech Health Products , Ltd. HIS Class II 1998-04-01
K974819 SELECTCELLS(TM) MINI Select Medical Systems, Inc. HHK Class II 1998-03-23
K980247 GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM Gynex Corp. HDC Class II 1998-03-17
K971565 BICOAG COAGULATING FORCEPS Everest Medical Corp. HIN Class II 1998-03-12
K974563 COLPO CUP CVC-2000 Clinical Innovations, Inc. HDP Class II 1998-03-02
K971028 WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED Worlds-Best Gummivarefabrik A/S HIS Class II 1998-03-02
K980061 EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER Rocket Medical Plc MFD Class II 1998-03-02
K974389 KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER Clinical Innovations, Inc. HFN Class II 1998-02-19
K974297 GALILEO DISPOSABLE HYSTEROSCOPES Netoptix Corp. HIH Class II 1998-02-13
K972856 ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS Rocket Medical Plc KNF Class II 1998-02-11
K974323 LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT Reddy Medtech Health Products , Ltd. HIS Class II 1998-02-10
K974629 O.B. APPLICATOR AND NON-APPLICATOR TAMPONS Personal Products Co. HEB Class II 1998-02-10
K974326 LATEX CONDOMS (NATURAL COLOUR) Reddy Medtech Health Products , Ltd. LTZ Class II 1998-02-09
K974324 LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT Reddy Medtech Health Products , Ltd. LTZ Class II 1998-02-09
K974357 UTERINE MANIPULATOR/INJECTOR Catheter Research, Inc. LKF Class II 1998-02-02
K972630 COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM CooperSurgical, Inc. HEX Class II 1998-02-02
K974138 ROCKET ELECTRODE A & A Medical, Inc. HGI Class II 1998-01-30
K974121 LUBRICATED BAGGY TACTYLON CONDOM Sensicon Corp. MOL Class II 1998-01-29
K970866 FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER Georgia Biomedical, Inc. HIF Class II 1998-01-23
K972488 KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES Karl Storz Endoscopy HET Class II 1998-01-22
K974028 STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING Conceptus, Inc. MKO Class II 1998-01-21
K970577 GLYDE DAM LOLLYES Glyde USA, Inc. MSC Class II 1998-01-08
K974036 PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE The Prometheus Group HIR Class II 1997-12-22
K974032 ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR A & A Medical, Inc. HFC Class II 1997-12-22
K962985 KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. HET Class II 1997-12-19
K973853 KOLPLAST VAGINAL SPECULUM Kolplast Comercial E Industrial Ltda HIB Class II 1997-12-19
K965008 BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM Spacelabs Medical, Inc. HGM Class II 1997-12-16
K963391 SPECULITE Trylon Corp. MPU Class II 1997-12-12
K973942 SWIFT DELIVERY PRODUCT #300 Swift Delivery Products HDB Class II 1997-12-12
K973737 MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M Richard Wolf Medical Instruments Corp. HET Class II 1997-12-12
K974227 HOSPITAL'S CLAMP Gps HFW Class II 1997-12-12
K974286 CIRCUMCISION TRAY, CAT. NO. 70340 Trinity Laboratories, Inc. HFX Class II 1997-12-12
K974228 HOSPITAL'S SPEC Gps HIB Class II 1997-12-12
K973501 EXPRESSE AND PREMIER POWERED BREAST PUMPS Ameda Medizintechnik AG HGX Class II 1997-12-11
K970078 HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM Davol Inc., Sub. C. R. Bard, Inc. HIG Class II 1997-12-11
K973432 SURGIFLATOR-30 W.O.M. World of Medicine GmbH HIF Class II 1997-12-09
K973304 MVM 3.3 MM MICROENDOSCOPE KARL STORZ Endoscopy-America, Inc. HET Class II 1997-12-02
K973780 PERSONAL LUBRICATING LIQUID Qualis, Inc. HIS Class II 1997-11-26
K973671 ENDOCERVICAL BLOCK NEEDLE A & A Medical, Inc. HEE Class II 1997-11-26
K964276 ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR Richard Wolf Medical Instruments Corp. HEW Class II 1997-11-25
K971793 VERY PRIVATE INTIMATE MOISTURE Brandwynne Corp. HIS Class II 1997-11-24
K973746 PRE-FILLED SYRINGE FOR KOALA IUP Clinical Innovations, Inc. HFN Class II 1997-11-24
K960552 KNIGHT LIGHT NONLUBRICATED CONDOM Global Protection Corp. HIS Class II 1997-11-20
K973850 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 Alexander Mfg. Co. HFO Class II 1997-11-12
K971836 VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR CooperSurgical, Inc. HET Class II 1997-11-07
K971838 MICRO ELECTRODES CooperSurgical, Inc. KNF Class II 1997-11-05
K970488 HYDROCHECK MICRO FILTER White River Concepts HGX Class II 1997-11-04
K971420 MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212) Richard Wolf Medical Instruments Corp. HIH Class II 1997-10-22
K972836 ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS G. Premjee (Usa), Inc. LTZ Class II 1997-10-22
K972823 MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER A & A Medical, Inc. MFD Class II 1997-10-10
K971896 GALILEO HIGH RESOLUTION MICRO COUPLER Netoptix Corp. HET Class II 1997-10-10
K971590 TACTYLON CONDOM Sensicon Corp. MOL Class II 1997-10-07
K970456 HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM Hewlett-Packard GmbH HGM Class II 1997-10-03
K971979 PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS Playtex Products, Inc. HIB Class II 1997-09-26
K972426 MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH Imagyn Medical, Inc. HIH Class II 1997-09-23
K971586 DIGENE CERVICAL BRUSH Digene Corp. HHT Class II 1997-09-19
K971543 LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP Kaweco GmbH HGX Class II 1997-09-18
K963711 BABY DOPPLEX (3000) Huntleigh Healthcare, Inc. HGM Class II 1997-09-12
K972429 INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 Custom Services Intl., Inc. LTZ Class II 1997-09-10
K972430 EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 Custom Services Intl., Inc. LTZ Class II 1997-09-10
K971492 AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR Bei Medical Systems Co., Inc. HIG Class II 1997-09-05
K972210 RESECTOSCOPE SAFETY SHEATH Conceptus, Inc. HIH Class II 1997-09-05
K970581 CLINIJEL Hospicon Products HIS Class II 1997-09-03
K971132 ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS G. Premjee (Usa), Inc. HIS Class II 1997-09-03
K972013 NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS National Healthcare Mfg. Corp. KNA Class II 1997-08-26
K971986 VALLEY FORGE BIPOLAR LOOP Valley Forge Scientific Corp. HGI Class II 1997-08-26
K971146 LAPARETTE Rd Chus, Inc. KNF Class II 1997-08-25
K972428 EXTRAWEAR, GENTLEMEN'S CHOICE Custom Services Intl., Inc. HIS Class II 1997-08-25
K971956 CRT2000 THERMOGRAPHIC SYSTEM Werner Eidam Medizin-Technologie GmbH LHQ Class I 1997-08-22
K972427 INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK Custom Services Intl., Inc. HIS Class II 1997-08-20
K964594 VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG) Circon Corp. KNF Class II 1997-08-15
K970145 PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) Biosearch Medical Products, Inc. HIR Class II 1997-08-11
K971305 FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM Gynecare Innovation Center HIH Class II 1997-08-11
K962271 ELECTROSURGICAL ELECRTRODES Northgate Technologies, Inc. HIH Class II 1997-08-08
K971837 VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820 CooperSurgical, Inc. HET Class II 1997-08-06
K962777 AMR MINI-LAPAROSCOPE Applied Medical Resources HET Class II 1997-08-06
K972245 TOM CAT F.L., TOM CAT S.L. A & A Medical, Inc. MFD Class II 1997-08-06
K955477 HI-TEC CO2 INSUFFLATOR TYPE 1300 Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz HIF Class II 1997-08-06
K971518 KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. HIH Class II 1997-07-24

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