FDA Review Panel · OB

FDA 510(k) Obstetrics & Gynecology Devices

FDA 510(k) Obstetrics & Gynecology Devices - Regulatory Overview

FDA 510(k) obstetrics and gynecology (OB/GYN) devices include diagnostic and therapeutic equipment for women's reproductive health. The FDA review panel code is OB.

Key categories:

  • Fetal monitoring systems - CTG monitors, fetal dopplers, scalp electrodes
  • Intrauterine devices (IUDs) - hormonal and copper contraceptive devices
  • Breast pumps and lactation aids - electric and manual breast pumps
  • Gynecological surgical instruments - hysteroscopes, laparoscopic tools, ablation systems
  • Pregnancy test systems - hCG detection devices for professional and home use

4525
Total
4511
Cleared
167d
Avg (2y)
1976
Since
4525 Obstetrics & Gynecology devices
2651–2675 of 4525
Cleared Nov 21, 1995
FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)
K953470 · Mediquip, Inc.
HHD · Pad, Menstrual, Unscented · 120d
Cleared Nov 21, 1995
SELECTCELLS STANDARD
K954097 · Select Medical Systems, Inc.
HHK · Curette, Suction, Endometrial (and Accessories) · 82d
Cleared Nov 21, 1995
SELECTMUCUS
K954102 · Select Medical Systems, Inc.
HFC · Aspirator, Endocervical · 82d
Cleared Nov 20, 1995
HYSTEROSYS FLEXIBLE HYSTEROCOPE
K951946 · Ovamed Corp.
HIH · Hysteroscope (and Accessories) · 208d
Cleared Nov 17, 1995
OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM
K943305 · Olympus America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 497d
Cleared Nov 16, 1995
ECHOMARK INTRAUTERINE GUIDING CATHETER
K932436 · Echocath, Inc.
MOV · Catheters, Salpingography · 911d
Cleared Nov 16, 1995
KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE
K935716 · KARL STORZ Endoscopy-America, Inc.
HIH · Hysteroscope (and Accessories) · 716d
Cleared Nov 16, 1995
HYSTERSCOPE
K940316 · Stephen Chakoff, Inc.
HIH · Hysteroscope (and Accessories) · 661d
Cleared Nov 13, 1995
OB/GYN PACKS
K951081 · Sterile Concepts, Inc.
KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 249d
Cleared Nov 08, 1995
PESSARY FLEXIBLE SILICONE NICHOLS
K920633 · Bioteque America, Inc.
KXP · Stent, Vaginal · 1365d
Cleared Nov 08, 1995
KIMONO MICROTHIN
K946374 · Mayer Laboratories
HIS · Condom · 329d
Cleared Nov 06, 1995
HUMAN TUBAL FLUID
K953719 · Life Technologies, Inc.
MFD · Cannula, Intrauterine Insemination · 89d
Cleared Nov 06, 1995
KARL STORZ TAKE-APART BIOPOLAR FORCEPS
K953809 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 89d
Cleared Nov 01, 1995
UNSCENTED MENSTRUAL PAD
K953633 · Tendasoft, Inc.
HHD · Pad, Menstrual, Unscented · 89d
Cleared Nov 01, 1995
UNSCENTED CURVED ULTRATHIN MAXI PADS
K953667 · Paragon Trade Brands, Inc.
HHD · Pad, Menstrual, Unscented · 86d
Cleared Nov 01, 1995
UNSCENTED ULTRATHIN MAXI PAD
K953668 · Paragon Trade Brands, Inc.
HHD · Pad, Menstrual, Unscented · 86d
Cleared Oct 31, 1995
OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN
K942838 · Olympus America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 503d
Cleared Oct 31, 1995
IMAGYN HYSTEROSCOPE SHEATHS
K952032 · Imagyn Medical, Inc.
HIH · Hysteroscope (and Accessories) · 183d
Cleared Oct 27, 1995
UNSCENTED MENSTRAL PAD
K953553 · Paragon Trade Brands, Inc.
HHD · Pad, Menstrual, Unscented · 91d
Cleared Oct 26, 1995
UNSCENTED MENSTRUAL PAD
K953517 · Paragon Trade Brands, Inc.
HHD · Pad, Menstrual, Unscented · 91d
Cleared Oct 20, 1995
HYS-SURGIMAT
K934866 · W.O.M. World of Medicine GmbH
HIG · Insufflator, Hysteroscopic · 738d
Cleared Oct 20, 1995
KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
K951105 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 224d
Cleared Oct 20, 1995
O.B. APPLICATOR TAMPONS
K953638 · Personal Products Co.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 77d
Cleared Oct 16, 1995
MEDELAS BREAST PUMP
K950750 · Medela, Inc.
HGX · Pump, Breast, Powered · 241d
Cleared Oct 16, 1995
ADEL 5000
K950889 · Stryker Corp.
HDD · Table, Obstetrical, Ac-powered (and Accessories) · 230d

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All categories 4525 HIS Condom 401 HET Laparoscope, Gynecologic (and Accessories) 335 MQL Media, Reproductive 259 HGX Pump, Breast, Powered 254 NUC Lubricant, Personal 249 HGM System, Monitoring, Perinatal 209 HEB Tampon, Menstrual, Unscented 189 HIF Insufflator, Laparoscopic 177 HIH Hysteroscope (and Accessories) 173 HHD Pad, Menstrual, Unscented 136 LKF Cannula, Manipulator/injector, Uterine 87 HIL Tampon, Menstrual, Scented, Scented-deodorized 84 HIB Speculum, Vaginal, Nonmetal 72 HHT Spatula, Cervical, Cytological 70 KNA Instrument, Manual, Specialized Obstetric-gynecologic 58