meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
32
Latest Decision
1997-07-24

Clearances · page 26 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K971849 CYTOLOGY BRUSH Team Technologies, Inc. HHT Class II 1997-07-24
K971797 LAPAROSCOPIC BLADDER NECK SUSPENSION KIT Louisville Laboratories, Inc. HET Class II 1997-07-22
K965245 TBD Utah Medical Products, Inc. HGI Class II 1997-07-03
K971809 ISOLATE Irvine Scientific Sales Co., Inc. MQL Class II 1997-07-03
K971188 SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS Smith & Nephew, Inc. HIH Class II 1997-06-27
K971621 RESISTICK SOLID LAPAROSCOPIC ELECTRODES Aaron Medical Industries KNF Class II 1997-06-20
K971547 PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS Playtex Products, Inc. HIL Class II 1997-06-19
K925501 NYLON COATED SPECULA Zinnanti Surgical Instruments, Inc. HIB Class II 1997-06-13
K963653 WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM Wallach Surgical Devices, Inc. HGI Class II 1997-06-11
K964679 WHITE RIVER AUTOMATIC BREAST PUMP White River Concepts HGX Class II 1997-06-10
K970954 O.B. APPLICATOR TAMPONS Personal Products Co. HEB Class II 1997-06-10
K971303 INSTEAD, SOFTCUP Ultrafem, Inc. HHE Class II 1997-06-06
K964396 DOUBLE UP BREAST PUMP The Natural Choice Co., Inc. HGX Class II 1997-06-06
K971240 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 Alexander Mfg. Co. HEL Class II 1997-06-06
K971099 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169 Alexander Mfg. Co. HGM Class II 1997-06-05
K970791 INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY Custom Services Intl., Inc. LTZ Class II 1997-06-03
K970792 INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE Titan Condoms HIS Class II 1997-06-02
K970767 CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTH Custom Services Intl., Inc. HIS Class II 1997-06-02
K963423 KSEA CO2 ENDOFLATOR Karl Storz Endoscopy HIF Class II 1997-05-27
K971174 PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS Playtex, Inc. HEB Class II 1997-05-21
K971277 SAFE-T-CLAMP Talon Medical, Ltd. KNA Class II 1997-05-20
K971231 WHITE RIVER MINI MANUAL BREAST PUMP White River Concepts HGY Class I 1997-05-19
K970750 MICROSPAN INSEMINATION SYSTEM Imagyn Medical, Inc. MFD Class II 1997-05-05
K965045 TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE Ethicon Endo-Surgery, Inc. HET Class II 1997-05-05
K963223 EZ-CIRC Phyllis Adams, Rn, Npc, Msn HFW Class II 1997-04-23
K963593 IMT LOUPE-COLPOSCOPE Inventive Medical Technology HEX Class II 1997-04-22
K960553 CARD GUARD MODEL CG-900 Card Guard Scientific Survival , Ltd. HGM Class II 1997-04-22
K971255 IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER Imagyn Medical, Inc. HET Class II 1997-04-21
K963889 QFC UMBILICAL CLAMP Qfc Industries HFW Class II 1997-04-18
K970492 INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER Ackrad Laboratories LKF Class II 1997-04-09
K963801 PAP BRUSH Young OU Brush Co. HHT Class II 1997-04-09
K971228 FEMTEX 100% COTTON TAMPONS Regu-Tech Assoc., Inc. HEB Class II 1997-04-09
K963076 LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY Louisville Laboratories, Inc. HET Class II 1997-04-04
K970108 HARMONIES MENSTRUAL TAMPON Ecoprogress Intl. HEB Class II 1997-04-03
K963428 UMBILICAL CLAMP AND CUTTER R.O.S.T. Medical Development, Inc. HFW Class II 1997-04-01
K970170 SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE Richard G. Lindsay HDB Class II 1997-03-28
K964441 FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU Gynecare Innovation Center KNF Class II 1997-03-28
K970232 FEMTEX 100% COTTON DENTLE TOUCH TAMPONS Regu-Tech Assoc., Inc. HEB Class II 1997-03-21
K970633 TUSTEX FLAVORED CONDOMS Line One Laboratories HIS Class II 1997-03-21
K965121 CANNULA Origin Medsystems, Inc. HET Class II 1997-03-20
K963348 WALLACH INTEGRATION UNIT Wallach Surgical Devices, Inc. HGI Class II 1997-03-19
K970151 INTERCEPTRE LAPAROSCOPIC INSTRUMENTS Smith & Nephew, Inc. HET Class II 1997-03-18
K963608 QUANTITATIVE SENTINEL SYSTEM Quantitative Medicine, Inc. HGM Class II 1997-03-11
K965040 INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL Johnson & Johnson Medical, Inc. HHW Class II 1997-03-10
K954488 ROLLER ELECTRODE Olympus America, Inc. HIH Class II 1997-03-06
K970282 MEDLINE CIRCUMCISION TRAY Medline HFX Class II 1997-03-06
K965055 IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES Imagyn Medical, Inc. HET Class II 1997-03-06
K970105 RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS Richard Wolf Medical Instruments Corp. HET Class II 1997-03-04
K964770 COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR Ge Medical Systems Information Technologies HGM Class II 1997-02-21
K965064 ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON Rostam , Ltd. HEB Class II 1997-02-20
K960727 EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT Evenflo Co., Inc. HGX Class II 1997-02-14
K963505 TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM Tenet Medical Engineering HHP Class II 1997-02-14
K960640 S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh HET Class II 1997-02-14
K964599 TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR Line One Laboratories HIS Class II 1997-02-14
K964598 TRUSTEX COLA FLAVORD CONDOM Line One Laboratories HIS Class II 1997-02-14
K964591 TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR Line One Laboratories HIS Class II 1997-02-13
K955183 SAFE KNIGHTS L & N Corp. HIS Class II 1997-02-11
K962828 EVERT-IT Genesis Industries, Inc. HGY Class I 1997-02-10
K962246 RIGID FIBER OPTIC LAPAROSCOPE Health Care International Assoc. HET Class II 1997-02-07
K962587 CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM Conceptus, Inc. MKO Class II 1997-01-31
K963580 IMAGYN FALLOPOSCOPY SYSTEM Imagyn Medical, Inc. MKO Class II 1997-01-31
K964436 WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM Western Surgical Instrument Co. HET Class II 1997-01-30
K964379 KSEA PUNCTURE CANNULA KARL STORZ Endoscopy-America, Inc. HET Class II 1997-01-29
K963319 OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN Custom Services Intl., Inc. HIS Class II 1997-01-22
K963322 OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN Custom Services Intl., Inc. LTZ Class II 1997-01-22
K963321 OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN Custom Services Intl., Inc. HIS Class II 1997-01-22
K964279 SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) Graphic Controls Corp. KXO Class II 1997-01-22
K963872 FEMRX MORCELLATOR SYSTEM Gynecare Innovation Center HET Class II 1997-01-17
K960508 PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 The Prometheus Group HIR Class II 1997-01-16
K964848 WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM Marlow Surgical Technologies, Inc. MFD Class II 1997-01-16
K964403 SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068) The First Years, Inc. HGX Class II 1997-01-13
K962683 SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR Deknatel, Inc. HIF Class II 1997-01-10
K964136 HYSTERO CO2-PNEU 2221 Richard Wolf Medical Instruments Corp. HIG Class II 1997-01-10
K964450 SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT Pilling Weck Group HET Class II 1997-01-10
K955393 NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE Surgical Innovations Plc HIF Class II 1997-01-09
K963960 KSEA UNIMAT PLUS KARL STORZ Endoscopy-America, Inc. HET Class II 1996-12-20
K963949 KSEA UNIMAT PLUS KARL STORZ Endoscopy-America, Inc. HET Class II 1996-12-19
K955791 SURGIFLATOR-20 PIM W.O.M. World of Medicine GmbH HIF Class II 1996-12-17
K963679 LOVING SMARTER - SAFER SEX Loving Smarter, Inc. HIS Class II 1996-12-12
K963852 KSEA THERMOCOAGULATOR (MODEL 265100 20) KARL STORZ Endoscopy-America, Inc. HGI Class II 1996-12-10
K962256 GALILEO HYSTEROSCOPES AND LAPAROSCOPES Galileo Electro-Optics Corp. HIH Class II 1996-12-06
K955073 KSEA THERMOFLATOR (MODEL 26 4320 20) KARL STORZ Endoscopy-America, Inc. HIF Class II 1996-12-06
K964269 PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS Playtime Products, Inc. HIL Class II 1996-11-29
K962816 SPERM PREPARATION MEDIA Genx Intl., Inc. MOL Class II 1996-11-26
K955756 KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR KARL STORZ Endoscopy-America, Inc. HGI Class II 1996-11-26
K954311 KOH COLPOTOMIZER SYSTEM CooperSurgical, Inc. HEW Class II 1996-11-19
K962863 KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR KARL STORZ Endoscopy-America, Inc. HIF Class II 1996-11-19
K961460 LWEET CONE BIOPSY INSTRUMENT Apple Medical Corp. HGI Class II 1996-11-19
K961605 KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE KARL STORZ Endoscopy-America, Inc. HIH Class II 1996-11-13
K962482 SCUBA SYSTEM Gynecare, Inc. HIH Class II 1996-11-01
K963034 FEMTEX GENTLE TOUCH TAMPONS First Quality Hygienic, Inc. HEB Class II 1996-11-01
K963287 VACUUM CUP (004SD) Swift Delivery Products HDB Class II 1996-10-28
K960299 PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE Richard Wolf Medical Instruments Corp. HET Class II 1996-10-28
K962881 KSEA CULDOCENTESIS SET Karl Storz Endoscopy HEW Class II 1996-10-22
K960810 BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM Marlo Surgical Technology HET Class II 1996-10-21
K963031 GENXCATHETER Genx Intl., Inc. MFD Class II 1996-10-21
K961290 IUP - TIP TRANS, IUP - PROXI TRANS Scientific Device Manufacturer, LLC KXO Class II 1996-10-15
K961688 MICROSPAN HYSTEROSCOPE Imagyn Medical, Inc. HIH Class II 1996-10-15
K963685 EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER North Eos Industries, Inc. HHT Class II 1996-10-11
K963032 FREE CHOICE First Quality Hygienic, Inc. HEB Class II 1996-10-11

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