meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
31
Latest Decision
1992-11-05

Clearances · page 33 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K922960 VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE Cameo, Inc. HIO Class I 1992-11-05
K915491 CURELLE Bioteque Corp. HHK Class II 1992-11-04
K920375 DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER Telos Medical Corp. HFN Class II 1992-10-27
K920187 FLEXIBLE SILICONE GELIHORN Bioteque America, Inc. HHW Class II 1992-10-23
K915138 GE SONOCHROME GE Medical Systems MAA Class II 1992-10-20
K915744 SHARPE ENDOHEMOSTAT Paladin Medical, Inc. HET Class II 1992-10-20
K915747 SHARPE ENDOFORCEPS Paladin Medical, Inc. HET Class II 1992-10-20
K915749 SHARPE ENDOLIGATURE CARRIER Paladin Medical, Inc. HET Class II 1992-10-20
K921888 SHARPE ENDODISSECTOR Paladin Medical, Inc. HET Class II 1992-10-20
K920803 HSG TRAY Unimar, Inc. HIB Class II 1992-10-19
K922038 CO2 INSUFFLATION TUBING Surgeon Surgical Instrumentation, Inc. HIF Class II 1992-10-13
K921264 SURGIFLATOR W.O.M. World of Medicine GmbH HIF Class II 1992-10-09
K912419 CORDGUARD BLOOD COLLECTION DEVICE O.B. Tech., Inc. HFW Class II 1992-10-05
K915331 AUTO SUTURE SURGIPORT DISPOSABLE ANCHORING DEVICE United States Surgical, A Division of Tyco Healthc HET Class II 1992-09-29
K915338 CONDUCTIVE SURGIGRIP SPIRAL SLEEVE United States Surgical, A Division of Tyco Healthc HET Class II 1992-09-28
K913242 MICROPROCESSED CONTROLLED LAPAROFLATOR Bryan Corp. HIF Class II 1992-09-25
K921222 FORCE 1C Valleylab, Inc. HGI Class II 1992-09-23
K915569 UMBILICAL CLAMP Gam Industries, Inc. HFW Class II 1992-09-23
K920549 SHARPE ENDONEEDLE HOLDER Paladin Medical, Inc. HET Class II 1992-09-22
K920548 SHARPE ENDOSCALPEL Paladin Medical, Inc. HET Class II 1992-09-22
K914923 UNISURGE DISPOSABLE TROCAR Unisurge, Inc. HET Class II 1992-09-21
K920353 ULTRACELL INSTRUMENT WIPE Ultracell Medical Technologies, Inc. HEP Class II 1992-09-15
K921963 DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 Sun Medical, Inc. HIF Class II 1992-09-11
K920830 NEW FREEDOM ULTRA THIN PADS Kimberly-Clark Corp. HHD Class I 1992-09-04
K914150 JANSEN-ANDERSON INSEMINATION SET Cook Ob/Gyn MFD Class II 1992-09-02
K912405 LATEX PROPHYLACTIC (CONDOM) Hevealactics Intl. Sdn Bhd HIS Class II 1992-07-21
K920959 INSUFFLATOR, LAPAROSCOPIC Mectra Labs, Inc. HIF Class II 1992-07-13
K915378 WECK TROCAR Edward Weck, Inc. HET Class II 1992-06-29
K913324 MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT Neward Enterprises, Inc. HDB Class II 1992-06-22
K915694 MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR Medical Devices, Inc. HIF Class II 1992-06-18
K913912 VERIMED PERINEOMETER Verimed Holdings, Inc. HIR Class II 1992-06-16
K915116 TROCAR SHEATH ANCHOR Origin Medsystems, Inc. HET Class II 1992-06-12
K920985 SNOWDEN-PENCER IRRIGATION PUMP Snowden-Pencer HEI Class II 1992-06-09
K920986 SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700 Snowden-Pencer HIF Class II 1992-06-04
K915051 MODIFICATION MODEL 7201 INSUFFLATOR Northgate Technologies, Inc. HIF Class II 1992-06-04
K913813 JIFFI CONDOM (RUBBER) CONTRACEPTIVE Sime Health, Ltd. HIS Class II 1992-06-01
K915388 LAPAROCOPIC MYOMA SCREW Cook Urological, Inc. HHO Class II 1992-05-18
K915412 HYSTEROSCOPIC MYOMA SCREW Cook Urological, Inc. HHO Class II 1992-05-18
K914367 ELECTROSURGICAL GENERATOR MODEL ESU100/250/550 Gyne-Tech Instrument Corp. HGI Class II 1992-04-28
K921738 SONO-VU US(TM), MODIFICATION E-Z-Em, Inc. HIO Class I 1992-04-27
K913365 ACCUSCOPE(TM) & ACCUSCOPE II(TM) Vineland Medical Products, Inc. HEX Class II 1992-04-27
K920376 COROMETRICS MODEL 150 FETAL MONITOR Ge Medical Systems Information Technologies HGM Class II 1992-04-27
K912093 DISPOSABLE ASPIRATION IRRIGATION SYSTEM Applied Urology, Inc. HET Class II 1992-04-24
K905536 FETAL DOPPLER Toshiba America Medical Systems, In.C MAA Class II 1992-04-21
K914309 THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES Hill-Rom, Inc. HDD Class II 1992-04-20
K912075 C-SECTION TRAY Medical Device Inspection Co., Inc. KNA Class II 1992-04-07
K920114 CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR Spiess Design, Inc. HIF Class II 1992-04-06
K920044 DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT Telos Medical Corp. KXO Class II 1992-04-03
K914329 SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION Ellman Intl. Mfg., Inc. HGI Class II 1992-04-02
K914153 OTT INSUFFLATOR FILTER PLUS/TUBING SET Marlo Surgical Technology HIF Class II 1992-04-02
K915863 MEGA AMNIOCENTESIS KIT Mega Medical, Inc. HIO Class I 1992-03-30
K913873 SYSTEM 3000 ELECTRONIC INSUFFLATOR Cabot Medical Corp. HIF Class II 1992-03-20
K914108 RG27-SERIES RESECTOSCOPE AND ACCESSORIES CooperSurgical, Inc. HIH Class II 1992-03-19
K912138 HOMEVUE MONITORING SYS.MODEL TD 2000 Homevue Health Systems, Inc. HGM Class II 1992-03-19
K915763 MODIFIED DISPOSABLE FETAL VACUUM Columbia Medical & Surgical, Inc. HDB Class II 1992-03-18
K913944 NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES American Surgical Instruments Corp. HET Class II 1992-03-09
K912941 TAMPON, UNTREATED Hygieia Healthcare , Ltd. HEB Class II 1992-03-06
K912046 SINGLE USE LEE ELECTRODE Aspen Labs HGI Class II 1992-03-05
K914241 PIONEER PRO-PUMP DUAL CONTROL Pioneer Medical, Inc. HHK Class II 1992-03-04
K914220 PIONEER PRO-PUMP Pioneer Medical, Inc. HHK Class II 1992-03-04
K915406 DAVOL ELECTROSUGICAL PROBES Davol, Inc. HFG Class II 1992-02-28
K913299 SOF-FLEX LAPAROSCOPIC BASKET Cook Ob/Gyn HET Class II 1992-02-14
K913213 SINGLE USE LEE ELECTRODE Aspen Laboratories, Inc. HGI Class II 1992-02-13
K903663 MEDSCOPE 8MM AND 10MM LAPAROSCOPE Medscope Corp. HET Class II 1992-02-11
K915297 TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM Lifeguard Medical Products, Inc. HET Class II 1992-02-11
K914968 DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR ETHICON, Inc. HET Class II 1992-02-03
K912901 TROJAN (TM-TBD) CONDOM Carter Products HIS Class II 1992-02-03
K912882 INNERVISION LAPAROSCOPE AND ACCESSORIES M.D. Engineering, Inc. HET Class II 1992-01-24
K912054 LABOR DELIVERY TRAY Medical Device Inspection Co., Inc. HFW Class II 1992-01-21
K910742 MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER Graphic Controls Corp. KXO Class II 1992-01-14
K914201 LM- LAP 10 HIGH FLOW INSUFFLATOR Leisegang Medical, Inc. HIF Class II 1992-01-09
K912890 MODEL SONICAID AXIS Oxford Medilog, Inc. HGM Class II 1992-01-09
K914438 PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS Playtex Family Products, Inc. HIL Class II 1992-01-02
K912639 SONICAID TEAM Oxford Medilog, Inc. HGM Class II 1991-12-31
K914387 TRANSCERVICAL INTRAUTERINE KIT Telos Medical Corp. HGS Class II 1991-12-30
K912498 THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR KARL STORZ Endoscopy-America, Inc. HIG Class II 1991-12-18
K910470 CONDOMS, MOODS/SHARE & RAKSHAK Hindustan Latex , Ltd. HIS Class II 1991-12-18
K912398 ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF ETHICON, Inc. HET Class II 1991-12-17
K910815 CR SPIRAL ELECTRODE Neward Enterprises, Inc. HGP Class II 1991-12-10
K910983 IV 1000 INSUFFLATOR RAPID FLOW M.D. Engineering, Inc. HIF Class II 1991-12-09
K912869 WOMEN AND INFANT'S DELIVERY PACK Welcon, Inc. HFW Class II 1991-12-04
K913979 ENDO I/A Y SET Snowden-Pencer HIF Class II 1991-11-27
K914402 RECIRCULATION KIT #7-510-18 Northgate Technologies, Inc. HIF Class II 1991-11-27
K914403 GENERAL USE KIT #7-510-20 Northgate Technologies, Inc. HIF Class II 1991-11-27
K914401 UNIVERSAL GENERAL USE KIT #7-510-16 Northgate Technologies, Inc. HIF Class II 1991-11-27
K914101 CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR Circon Video HIF Class II 1991-11-22
K911844 HYSTEROFLATOR 1500 F.M. Wiest USA, Inc. HIG Class II 1991-11-21
K913772 PRESSURE GUARD Beacon Laboratories, Inc. HIF Class II 1991-11-19
K911179 VERRES NEEDLES 5 & 6 INCHES Northgate Technologies, Inc. HIF Class II 1991-11-13
K913835 SNOWDEN-PENCER INSUFFLATOR TUBING SET Snowden-Pencer HIF Class II 1991-11-07
K913747 STAYFREE(TM) MAXI-PAD Personal Products Co. HHD Class I 1991-11-05
K912552 UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR Personal Products Co. HEB Class II 1991-09-24
K913237 ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD Procter & Gamble Co. HHL Class II 1991-09-23
K913238 ALWAYS, UNSCENTED MENSTRUAL PAD Procter & Gamble Co. HHL Class II 1991-09-23
K912789 LM-100/200LOW FLOW INSUFFLATOR Leisegang Medical, Inc. HIG Class II 1991-09-20
K905263 UTAH ESSU Utah Medical Products, Inc. HGI Class II 1991-09-18
K905747 LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR Coopervision Surgical HGI Class II 1991-09-17
K910982 INNERVISION IRRIGATION PUMP M.D. Engineering, Inc. HEI Class II 1991-08-26
K910921 AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV United States Surgical, A Division of Tyco Healthc HET Class II 1991-08-26
K902772 PLEASURE PLUS Medimix Products, Inc. HIS Class II 1991-08-14

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