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
3164 Obstetrics & Gynecology devices
2301–2325 of 3164
Cleared Feb 07, 1995
DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER
K945789 · Deroyal Industries, Inc.
HIF · Insufflator, Laparoscopic · 74d
Cleared Jan 30, 1995
CONDOM
K940045 · Ansell, Inc.
HIS · Condom · 390d
Cleared Jan 30, 1995
NON-LUBRICATED CONDOM
K940046 · Ansell, Inc.
HIS · Condom · 390d
Cleared Jan 26, 1995
IMAGYN MICROLAP INTRODUCER
K943810 · Imagyn Medical, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 174d
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 20, 1995
IMAGYN MICROLAP(TM) LAPAROSCOPE
K944079 · Imagyn Medical, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 151d
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
BARD HYSTERO-FLO II PUMP
K933384 · Davol Inc., Sub. C. R. Bard, Inc.
HIG · Insufflator, Hysteroscopic · 536d
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
Cleared Dec 21, 1994
UNSCENTED MENSTRUAL TAMPONS
K944834 · Tambrands, Inc.
HEB · Tampon, Menstrual, Unscented · 82d
Cleared Dec 15, 1994
HASSON OPEN LAPAROSCOPY CANNULA
K942447 · Linvatec Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 206d
Cleared Dec 15, 1994
KARL STORZ INSULATED SCISSORS
K944297 · KARL STORZ Endoscopy-America, Inc.
KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 100d
Cleared Dec 15, 1994
KARL STORZ INSULATED BIOPSY FORCEPS
K944300 · KARL STORZ Endoscopy-America, Inc.
KNF · Coagulator-cutter, Endoscopic, Unipolar (and Accessories) · 100d
Cleared Dec 12, 1994
FINESSE IEC/601
K941251 · Utah Medical Products, Inc.
HGI · Electrocautery, Gynecologic (and Accessories) · 272d
Cleared Dec 05, 1994
R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050
K935301 · R & D Batteries, Inc.
HGM · System, Monitoring, Perinatal · 397d
Cleared Dec 05, 1994
R AND D BATTERIES
K935377 · R & D Batteries, Inc.
HGM · System, Monitoring, Perinatal · 392d
Cleared Nov 30, 1994
LAPAROVIEW
K931065 · Northgate Technologies, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 639d
Cleared Nov 17, 1994
INSUFFLATOR TUBING WITH FILTER
K943508 · Stryker Endoscopy
HET · Laparoscope, Gynecologic (and Accessories) · 120d
Cleared Nov 15, 1994
ELMED LBC 50-P
K926517 · Elmed, Inc.
HIN · Coagulator-cutter, Endoscopic, Bipolar (and Accessories) · 685d

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All categories 3164 NUC Lubricant, Personal 230 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 HIG Insufflator, Hysteroscopic 43 MQK Labware, Assisted Reproduction 43