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

4478
Total
4465
Cleared
163d
Avg (2y)
1976
Since
849 Obstetrics & Gynecology devices
751–775 of 849
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 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 07, 1995
KARL STORZ SUCTION CATHETERS
K951250 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 171d
Cleared Aug 04, 1995
V. MUELLER OBSTETRICAL (OB) FORCEPS
K951529 · Baxter Healthcare Corp
HDA · Forceps, Obstetrical · 123d
Cleared Aug 04, 1995
ELECTRONIC LAPAROFLATOR
K951694 · KARL STORZ Endoscopy-America, Inc.
HIF · Insufflator, Laparoscopic · 114d
Cleared Aug 01, 1995
KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR
K951961 · KARL STORZ Endoscopy-America, Inc.
HIF · Insufflator, Laparoscopic · 97d
Cleared Jul 20, 1995
KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODE
K951394 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 114d
Cleared Jul 12, 1995
KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
K950962 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 132d
Cleared Jun 19, 1995
KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS
K950639 · KARL STORZ Endoscopy-America, Inc.
MOK · Vaginoscope And Accessories · 126d
Cleared Jun 15, 1995
B-D DIGITAL THERMOMETER
K945427 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LHD · Device, Fertility Diagnostic, Proceptive · 223d
Cleared Jun 14, 1995
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE
K951190 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 90d
Cleared May 25, 1995
KSE STEINER ELECTROMECHANIC MORCELLATOR
K946147 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 160d
Cleared May 25, 1995
KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
K950961 · KARL STORZ Endoscopy-America, Inc.
HIG · Insufflator, Hysteroscopic · 84d
Cleared May 11, 1995
KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS
K946359 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 132d
Cleared May 05, 1995
KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS
K945685 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 165d
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 21, 1995
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER
K945982 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 103d
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 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 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 15, 1994
KARL STORZ INSULATED SCISSORS
K944297 · KARL STORZ Endoscopy-America, Inc.
KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 100d

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All categories 849 HGX Pump, Breast, Powered 128 NUC Lubricant, Personal 117 HIH Hysteroscope (and Accessories) 70 HET Laparoscope, Gynecologic (and Accessories) 59 MQL Media, Reproductive 50 HIF Insufflator, Laparoscopic 37 HEB Tampon, Menstrual, Unscented 37 HIS Condom 30 HGM System, Monitoring, Perinatal 25 LKF Cannula, Manipulator/injector, Uterine 17 MQK Labware, Assisted Reproduction 17 MQF Catheter, Assisted Reproduction 16 HIG Insufflator, Hysteroscopic 15 KNG Monitor, Ultrasonic, Fetal 13 KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories) 11