meddevicedb.com FDA Device Reference

Review Panel

Obstetrics/Gynecology FDA 510(k) Clearances & Devices

Cleared Devices
4,626
Product Codes (page)
33
Latest Decision
1995-11-22

Clearances · page 28 of 47

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K952465 PROBE PERSONAL LUBRICANT - SILKY LIGHT Davryan Laboratories, Inc. HIS Class II 1995-11-22
K952464 PROBE PERSONAL LUBRICANT - CLASSIC Davryan Laboratories, Inc. HIS Class II 1995-11-22
K954099 SELECT IUI Select Medical Systems, Inc. MFD Class II 1995-11-22
K954102 SELECTMUCUS Select Medical Systems, Inc. HFC Class II 1995-11-21
K954097 SELECTCELLS STANDARD Select Medical Systems, Inc. HHK Class II 1995-11-21
K953470 FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS) Mediquip, Inc. HHD Class I 1995-11-21
K951946 HYSTEROSYS FLEXIBLE HYSTEROCOPE Ovamed Corp. HIH Class II 1995-11-20
K943305 OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM Olympus America, Inc. HET Class II 1995-11-17
K932436 ECHOMARK INTRAUTERINE GUIDING CATHETER Echocath, Inc. MOV Class II 1995-11-16
K935716 KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE KARL STORZ Endoscopy-America, Inc. HIH Class II 1995-11-16
K940316 HYSTERSCOPE Stephen Chakoff, Inc. HIH Class II 1995-11-16
K951081 OB/GYN PACKS Sterile Concepts, Inc. KNA Class II 1995-11-13
K946374 KIMONO MICROTHIN Mayer Laboratories HIS Class II 1995-11-08
K920633 PESSARY FLEXIBLE SILICONE NICHOLS Bioteque America, Inc. KXP Class II 1995-11-08
K953719 HUMAN TUBAL FLUID Life Technologies, Inc. MFD Class II 1995-11-06
K953809 KARL STORZ TAKE-APART BIOPOLAR FORCEPS KARL STORZ Endoscopy-America, Inc. HET Class II 1995-11-06
K953633 UNSCENTED MENSTRUAL PAD Tendasoft, Inc. HHD Class I 1995-11-01
K953667 UNSCENTED CURVED ULTRATHIN MAXI PADS Paragon Trade Brands, Inc. HHD Class I 1995-11-01
K953668 UNSCENTED ULTRATHIN MAXI PAD Paragon Trade Brands, Inc. HHD Class I 1995-11-01
K952032 IMAGYN HYSTEROSCOPE SHEATHS Imagyn Medical, Inc. HIH Class II 1995-10-31
K942838 OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN Olympus America, Inc. HET Class II 1995-10-31
K953553 UNSCENTED MENSTRAL PAD Paragon Trade Brands, Inc. HHD Class I 1995-10-27
K953517 UNSCENTED MENSTRUAL PAD Paragon Trade Brands, Inc. HHD Class I 1995-10-26
K951105 KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP KARL STORZ Endoscopy-America, Inc. HET Class II 1995-10-20
K934866 HYS-SURGIMAT W.O.M. World of Medicine GmbH HIG Class II 1995-10-20
K953638 O.B. APPLICATOR TAMPONS Personal Products Co. HIL Class II 1995-10-20
K954520 MICROSURGE VERESS NEEDLE Microsurge, Inc. HET Class II 1995-10-16
K950750 MEDELAS BREAST PUMP Medela, Inc. HGX Class II 1995-10-16
K950889 ADEL 5000 Stryker Corp. HDD Class II 1995-10-16
K942431 LAPOROSCOPIC SCISSORS Enterprise Medical Corp. HET Class II 1995-10-11
K953242 SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES Symbiosis Corp. KNF Class II 1995-10-06
K952483 LEEP SYSTEM 1000 CooperSurgical, Inc. HGI Class II 1995-10-06
K952779 KARL STORZ FLEXIBLE HYSTERSCOPE KARL STORZ Endoscopy-America, Inc. HIH Class II 1995-10-05
K953190 KSEA MODEL 203200 20 UNIMAT KARL STORZ Endoscopy-America, Inc. HET Class II 1995-10-05
K925681 MYOTRAC2D/CS Thought Technology , Ltd. HIR Class II 1995-09-29
K953574 NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER American Hydro-Surgical Instruments, Inc. HET Class II 1995-09-29
K944444 CIT BIOPSY PUNCHES Chirurgische Instrumente HFB Class I 1995-09-29
K940265 PATTON LAPAROSCOPIC CATHETER INTRODUCER SET Cook Urological, Inc. HET Class II 1995-09-28
K953700 UNSCENTED CURVED MAXI PAD Paragon Trade Brands, Inc. HHD Class I 1995-09-27
K953666 UNSCENTED MENSTRAL PAD WITH WINGS Paragon Trade Brands, Inc. HHD Class I 1995-09-27
K950531 EGNELL ELITE Hollister, Inc. HGX Class II 1995-09-22
K946376 MAXX Mayer Laboratories HIS Class II 1995-09-22
K943064 KIMONO (CONDOMS) Mayer Laboratories HIS Class II 1995-09-22
K953548 LAPAROSCOPIC SURGICAL INSTRUMENT Gabris Surgical Corp. HET Class II 1995-09-19
K946220 CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR Conmedcorp LKF Class II 1995-09-15
K944238 ENDOCYTE TM D.L. Nelson and Assoc., Inc. HCY Class I 1995-09-15
K952652 MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER Medscand (Usa), Inc. HHK Class II 1995-09-15
K944200 HI-Q HAND INSTRUMENTS, OB/GYN USE Olympus America, Inc. HET Class II 1995-09-15
K952034 MEDELA'S FOOT PUMP Medela, Inc. HGY Class I 1995-09-12
K945265 OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES Optus, Inc. HIH Class II 1995-09-12
K951250 KARL STORZ SUCTION CATHETERS KARL STORZ Endoscopy-America, Inc. HET Class II 1995-09-07
K945246 PREVENTOR AND PROTECTOR LATEX CONDOMS American Pharmaceutical Co., Inc. HIS Class II 1995-09-07
K953034 H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) Ackrad Laboratories LKF Class II 1995-08-29
K950194 TAMPON, UNTREATED Hygieia Healthcare , Ltd. HEB Class II 1995-08-25
K953109 HAND EXTRACTOR HECTOR Karl Storz Endoscopy HIH Class II 1995-08-25
K952508 FLOW-THERME, WISAP #7642 Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh HET Class II 1995-08-25
K930714 SONICAID MODEL TEAM FECG IUP Oxford Instruments, Plc. HEL Class II 1995-08-24
K950255 ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM Argus Medical Co., Inc. HIH Class II 1995-08-24
K952394 PLAYTEX TAMPONS #13695 Playtime Products, Inc. HEB Class II 1995-08-21
K933847 HYS-SURGIFLATOR VP W.O.M. World of Medicine GmbH HIG Class II 1995-08-15
K951835 MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE Life Technologies, Inc. MFD Class II 1995-08-11
K943100 STRYKER OPERATING LAPAROSCOPE Stryker Endoscopy HET Class II 1995-08-10
K953487 UNSCENTED MENSTRUAL SHIELD Paragon Trade Brands, Inc. HHD Class I 1995-08-09
K934552 PERIPUMP Deschutes Medical Products, Inc. HIR Class II 1995-08-09
K953488 UNSCENTED MENSTRUAL LINER Paragon Trade Brands, Inc. HHD Class I 1995-08-09
K952393 OKAMOTO CONDOM Okamoto USA, Inc. HIS Class II 1995-08-09
K951529 V. MUELLER OBSTETRICAL (OB) FORCEPS Baxter Healthcare Corp HDA Class II 1995-08-04
K952579 TOCO TRANSDUCER Scientific Device Manufacturer, LLC HFM Class II 1995-08-04
K951694 ELECTRONIC LAPAROFLATOR KARL STORZ Endoscopy-America, Inc. HIF Class II 1995-08-04
K951961 KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR KARL STORZ Endoscopy-America, Inc. HIF Class II 1995-08-01
K952344 SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS Tambrands, Inc. HIL Class II 1995-07-28
K952035 NIPLETTE Avent America, Inc. HGY Class I 1995-07-28
K931534 OVAMED INTRAUTERINE ACCESS CATHETER Ovamed Corp. MOV Class II 1995-07-28
K953314 CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM Conceptus, Inc. MOV Class II 1995-07-28
K931476 NOVY CORNUAL CANNULATION SET Cook Ob/Gyn MOV Class II 1995-07-28
K952070 NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS American Hydro-Surgical Instruments, Inc. KNF Class II 1995-07-26
K951693 CARESS SANITARY NAPKIN Sterling U.S.A., Inc. HHD Class I 1995-07-25
K945949 KILEJIAN CIRCUMCISION TEMPLATE [THE DOME] Vlm Surgical, Inc. HFX Class II 1995-07-25
K941206 DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE New Eder Corp. HET Class II 1995-07-25
K944270 CIT MONOPOLAR LAPAROSCOPIC INSTRMENTS Chirurgische Instrumente HET Class II 1995-07-25
K950780 AMSINO CERVICAL SCRAPER Amsino Intl., Inc. HHT Class II 1995-07-25
K944450 SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE Unimed Surgical Products, Inc. HGI Class II 1995-07-25
K952033 IMAGYN HYSTEROSCOPE Imagyn Medical, Inc. HIH Class II 1995-07-24
K950498 LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER Graphic Controls Corp. KXO Class II 1995-07-24
K951394 KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODE KARL STORZ Endoscopy-America, Inc. HET Class II 1995-07-20
K952031 ULTRASOUND TRANSDUCER, MODEL US917 Advanced Medical Systems, Inc. HGL Class II 1995-07-18
K951924 ORGANIC TAMPONS Eco Yarn Co. HEB Class II 1995-07-14
K945937 TE-800 PELVIC FLOOR EXERCISER Myo/Kinetic Systems, Inc. HIR Class II 1995-07-14
K950962 KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT KARL STORZ Endoscopy-America, Inc. HET Class II 1995-07-12
K943494 HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY Lyco Enterprises, Inc. LKF Class II 1995-07-06
K946380 NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V) American Hydro-Surgical Instruments, Inc. HET Class II 1995-07-06
K951806 OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000) Opgal Optronic Industries LHQ Class I 1995-07-06
K943713 TORCARS,CANNULAE,SHEATHS,OBTURATORS Karl Storz Endoskop GmbH HET Class II 1995-06-30
K943933 SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM Aladan Corp. HIS Class II 1995-06-22
K931167 OVAMED FALLOPIAN OSTIAL ACCESS CATHETER Ovamed Corp. LKF Class II 1995-06-22
K942697 TROJAN POLYURETHANE CONDOM Carter Products MOL Class II 1995-06-22
K950639 KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS KARL STORZ Endoscopy-America, Inc. MOK Class II 1995-06-19
K950499 NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS American Hydro-Surgical Instruments, Inc. KNF Class II 1995-06-16
K932985 AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI Sime Health, Ltd. HIS Class II 1995-06-16
K951190 KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE KARL STORZ Endoscopy-America, Inc. HET Class II 1995-06-14

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