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

4499
Total
4485
Cleared
168d
Avg (2y)
1976
Since
1727 Obstetrics & Gynecology devices
1076–1100 of 1727
Cleared Mar 11, 1996
OES LAPARO-THORACO VIDEOSCOPE TYPE V
K955403 · Olympus America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 105d
Cleared Mar 05, 1996
COROMETRICS FETAL MOVEMENT DETECTION KIT
K955559 · Ge Medical Systems Information Technologies
HGM · System, Monitoring, Perinatal · 90d
Cleared Feb 26, 1996
ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET
K955508 · Cook Urological, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 87d
Cleared Feb 22, 1996
OES LAPARO-THORACO VIDEOSCOPE (RIGID)
K955456 · Olympus America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 85d
Cleared Feb 20, 1996
INTRAN PLUS
K955443 · Utah Medical Products, Inc.
HFN · Transducer, Pressure, Intrauterine · 84d
Cleared Jan 02, 1996
BALLOON UTERINE STENT
K952527 · Cook Urological, Inc.
KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 215d
Cleared Dec 21, 1995
CORDGUARD II
K954619 · Utah Medical Products, Inc.
KNA · Instrument, Manual, Specialized Obstetric-gynecologic · 77d
Cleared Dec 19, 1995
OLYMPUS HIGH FLOW INSUFFLATION UNIT
K953162 · Olympus America, Inc.
HIF · Insufflator, Laparoscopic · 165d
Cleared Dec 19, 1995
INSEMI-CATH II
K954398 · Cook Urological, Inc.
MFD · Cannula, Intrauterine Insemination · 90d
Cleared Dec 11, 1995
VERSA-VU
K951898 · CooperSurgical, Inc.
HIB · Speculum, Vaginal, Nonmetal · 231d
Cleared Nov 17, 1995
OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM
K943305 · Olympus America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 497d
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 06, 1995
KARL STORZ TAKE-APART BIOPOLAR FORCEPS
K953809 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 89d
Cleared Oct 31, 1995
OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN
K942838 · Olympus America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 503d
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
ADEL 5000
K950889 · Stryker Corp.
HDD · Table, Obstetrical, Ac-powered (and Accessories) · 230d
Cleared Oct 06, 1995
LEEP SYSTEM 1000
K952483 · CooperSurgical, Inc.
HGI · Electrocautery, Gynecologic (and Accessories) · 129d
Cleared Oct 05, 1995
KARL STORZ FLEXIBLE HYSTERSCOPE
K952779 · KARL STORZ Endoscopy-America, Inc.
HIH · Hysteroscope (and Accessories) · 111d
Cleared Oct 05, 1995
KSEA MODEL 203200 20 UNIMAT
K953190 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 87d
Cleared Sep 28, 1995
PATTON LAPAROSCOPIC CATHETER INTRODUCER SET
K940265 · Cook Urological, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 615d
Cleared Sep 22, 1995
EGNELL ELITE
K950531 · Hollister, Inc.
HGX · Pump, Breast, Powered · 227d
Cleared Sep 15, 1995
HI-Q HAND INSTRUMENTS, OB/GYN USE
K944200 · Olympus America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 382d
Cleared Sep 15, 1995
CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR
K946220 · Conmedcorp
LKF · Cannula, Manipulator/injector, Uterine · 268d
Cleared Sep 07, 1995
KARL STORZ SUCTION CATHETERS
K951250 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 171d

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All categories 1727 HET Laparoscope, Gynecologic (and Accessories) 148 HGX Pump, Breast, Powered 129 NUC Lubricant, Personal 121 MQL Media, Reproductive 121 HIH Hysteroscope (and Accessories) 106 HEB Tampon, Menstrual, Unscented 100 HGM System, Monitoring, Perinatal 86 HIF Insufflator, Laparoscopic 80 HHD Pad, Menstrual, Unscented 54 LKF Cannula, Manipulator/injector, Uterine 43 HHL Pad, Menstrual, Scented, Scented-deodorized 38 HIS Condom 37 HIG Insufflator, Hysteroscopic 27 HIL Tampon, Menstrual, Scented, Scented-deodorized 24 MQF Catheter, Assisted Reproduction 24