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
1126–1150 of 1727
Cleared Mar 30, 1995
KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE
K945211 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 156d
Cleared Mar 29, 1995
AESCULAP LAPAROSCOPIC ANCILLARY DEVICES
K943603 · Aesculap, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 247d
Cleared Mar 21, 1995
ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP)
K942986 · Aaron Medical Industries
HGI · Electrocautery, Gynecologic (and Accessories) · 293d
Cleared Mar 21, 1995
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER
K945982 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 103d
Cleared Mar 16, 1995
LAPAROSCOPE AND ACCESSORIES FOR OB/GYN
K950232 · Olympus America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 66d
Cleared Mar 15, 1995
3000 ELECTRONIC INSUFFLATOR MODIFICATION
K934115 · Cabot Medical Corp.
HIF · Insufflator, Laparoscopic · 568d
Cleared Feb 28, 1995
CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020
K932276 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 657d
Cleared Feb 28, 1995
TROCAR AND CANNULA ACCESSORY
K945741 · Applied Medical Resources
HET · Laparoscope, Gynecologic (and Accessories) · 97d
Cleared Feb 21, 1995
A4722 OLYMPUS OPTICAL OBTURATOR
K950055 · Olympus America, Inc.
HIH · Hysteroscope (and Accessories) · 46d
Cleared Feb 13, 1995
IUMC ENDOMETRIAL SAMPLER
K941298 · Cook Ob/Gyn
HFE · Brush, Endometrial · 333d
Cleared Feb 13, 1995
CONMED 7/8MM GASKET REDUCER FOR USE WITH TROGARD(TM) TROCAR SLEEVE
K946235 · Conmedcorp
HET · Laparoscope, Gynecologic (and Accessories) · 53d
Cleared Feb 09, 1995
KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES
K944862 · KARL STORZ Endoscopy-America, Inc.
KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 129d
Cleared Feb 09, 1995
OLYMPUS 5FR SEMI-RIGID SCISSORS FOR OB/GYN
K950036 · Olympus America, Inc.
HIH · Hysteroscope (and Accessories) · 36d
Cleared Feb 07, 1995
MODEL 2231 CO2 INSUFFLATOR
K934884 · Richard Wolf Medical Instruments Corp.
HIF · Insufflator, Laparoscopic · 483d
Cleared Feb 07, 1995
DEXIDE INSUFFLATION TUBING WITH FILTER
K944509 · Dexide, Inc.
HIF · Insufflator, Laparoscopic · 145d
Cleared Feb 07, 1995
DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER
K945789 · Deroyal Industries, Inc.
HIF · Insufflator, Laparoscopic · 74d
Cleared Jan 25, 1995
UTERINE MANIPULATOR/INJECTOR WITH SPRING
K941458 · Zinnanti Surgical Instruments, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 306d
Cleared Jan 24, 1995
THE KARL STORZ HAMOU ENDOMAT
K936231 · Karl Storz Endoscopy
HIG · Insufflator, Hysteroscopic · 391d
Cleared Jan 24, 1995
UTERINE INJECTOR WITH SPRING
K941457 · Zinnanti Surgical Instruments, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 305d
Cleared Jan 24, 1995
KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES
K944793 · KARL STORZ Endoscopy-America, Inc.
KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 118d
Cleared Jan 24, 1995
KARL STORZ SUCTION/IRRIGATION TUBES, CANNULAE
K945100 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 98d
Cleared Jan 06, 1995
STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 360
K936273 · Baxter Healthcare Corp
HET · Laparoscope, Gynecologic (and Accessories) · 388d
Cleared Dec 30, 1994
ENDOSCOPE
K944555 · United States Surgical, A Division of Tyco Healthc
HET · Laparoscope, Gynecologic (and Accessories) · 105d
Cleared Dec 29, 1994
CONCEPT UNIVERSAL PUMP SYSTEM
K933873 · Linvatec Corp.
HIG · Insufflator, Hysteroscopic · 507d
Cleared Dec 21, 1994
CONMED TROGARD
K934799 · Conmedcorp
HET · Laparoscope, Gynecologic (and Accessories) · 440d

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All categories 1727 HET Laparoscope, Gynecologic (and Accessories) 148 HGX Pump, Breast, Powered 129 MQL Media, Reproductive 121 NUC Lubricant, Personal 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 OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed 24 HIL Tampon, Menstrual, Scented, Scented-deodorized 24