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

4507
Total
4493
Cleared
168d
Avg (2y)
1976
Since
3163 Obstetrics & Gynecology devices
2126–2150 of 3163
Cleared Oct 10, 1996
CONDOM
K960710 · Polar Latex , Ltd.
HIS · Condom · 232d
Cleared Oct 10, 1996
DEODORANT PANTY SHIELD
K962953 · Paragon Trade Brands, Inc.
HHL · Pad, Menstrual, Scented, Scented-deodorized · 72d
Cleared Oct 10, 1996
DEODORANT MAXI PAD
K962954 · Paragon Trade Brands, Inc.
HHL · Pad, Menstrual, Scented, Scented-deodorized · 72d
Cleared Oct 10, 1996
DEODORANT PANTY LINER
K962962 · Paragon Trade Brands, Inc.
HHL · Pad, Menstrual, Scented, Scented-deodorized · 72d
Cleared Oct 04, 1996
EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC
K963377 · North Eos Industries, Inc.
HIB · Speculum, Vaginal, Nonmetal · 38d
Cleared Oct 03, 1996
KARL STORZ MODEL 203020 20 EQUIMAT
K961091 · KARL STORZ Endoscopy-America, Inc.
HIG · Insufflator, Hysteroscopic · 198d
Cleared Sep 30, 1996
KARL STORZ MODEL 203210 O1 UNIMAT PLUS
K962090 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 124d
Cleared Sep 24, 1996
INSUFFLATION NEEDLE
K963359 · Applied Medical Resources
HET · Laparoscope, Gynecologic (and Accessories) · 29d
Cleared Sep 10, 1996
YSANPOINT) (MENSTRUAL) DIGITAL TAMPON
K962712 · Talbot S. Lindstrom
HEB · Tampon, Menstrual, Unscented · 60d
Cleared Aug 29, 1996
TROJAN POLYURETHANE CONDOM (MODIFICATION)
K955672 · Carter Products
MOL · Condom, Synthetic · 302d
Cleared Aug 29, 1996
CERVICAL MUCOUS ASPIRATION CATHETER
K960263 · Cook Urological, Inc.
HFC · Aspirator, Endocervical · 224d
Cleared Aug 29, 1996
MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE
K960549 · Neward Enterprises, Inc.
HDB · Extractor, Vacuum, Fetal · 203d
Cleared Aug 29, 1996
A4907 LENS CLEANING SHEATH
K961860 · Olympus America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 107d
Cleared Aug 14, 1996
MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)
K955931 · Advanced Medical Systems, Inc.
HGM · System, Monitoring, Perinatal · 243d
Cleared Aug 13, 1996
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
K962476 · Tambrands, Inc.
HEB · Tampon, Menstrual, Unscented · 49d
Cleared Aug 09, 1996
RDP-2
K961922 · Ranfac, Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 84d
Cleared Aug 08, 1996
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
K961752 · Ackrad Laboratories
LKF · Cannula, Manipulator/injector, Uterine · 94d
Cleared Aug 01, 1996
QUANTITATIVE SENTINEL SYSTEM
K960109 · Quantitative Medicine, Inc.
HGM · System, Monitoring, Perinatal · 203d
Cleared Jul 31, 1996
LOOP/SQUARE ELECTRODE
K952030 · E & M Engineering, Inc.
HGI · Electrocautery, Gynecologic (and Accessories) · 457d
Cleared Jul 31, 1996
MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST
K962273 · Marlo Surgical Technology
MFD · Cannula, Intrauterine Insemination · 48d
Cleared Jul 24, 1996
RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
K960936 · Origin Medsystems, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 138d
Cleared Jul 22, 1996
LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS
K953813 · London International U.S. Holdings, Inc.
LTZ · Condom With Nonoxynol-9 · 353d
Cleared Jul 22, 1996
EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP
K960726 · Evenflo Co., Inc.
HGX · Pump, Breast, Powered · 151d
Cleared Jul 17, 1996
KSEA SCALP BLOOD COLLECTION SET
K954982 · KARL STORZ Endoscopy-America, Inc.
HGK · Endoscope, Fetal Blood Sampling (and Accessories) · 260d
Cleared Jul 15, 1996
TRUSTEX FLAVOR CONDON IN COLORS
K946103 · Line One Laboratories & Trading Co.
HIS · Condom · 579d

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All categories 3163 NUC Lubricant, Personal 229 HET Laparoscope, Gynecologic (and Accessories) 225 MQL Media, Reproductive 217 HGX Pump, Breast, Powered 206 HIS Condom 197 HEB Tampon, Menstrual, Unscented 157 HGM System, Monitoring, Perinatal 155 HIH Hysteroscope (and Accessories) 145 HIF Insufflator, Laparoscopic 131 HIL Tampon, Menstrual, Scented, Scented-deodorized 75 HHD Pad, Menstrual, Unscented 64 LKF Cannula, Manipulator/injector, Uterine 61 HHL Pad, Menstrual, Scented, Scented-deodorized 45 MQK Labware, Assisted Reproduction 43 HIG Insufflator, Hysteroscopic 43