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
726–750 of 849
Cleared Jan 08, 1999
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K983569 · KARL STORZ Endoscopy-America, Inc.
HIH · Hysteroscope (and Accessories) · 87d
Cleared Sep 10, 1998
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
K982149 · Smith & Nephew, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 84d
Cleared Aug 19, 1998
KSEA ENDO TIP SYSTEM
K981130 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 142d
Cleared May 08, 1998
KSEA PLASTIC TROCARS
K980694 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 74d
Cleared Apr 15, 1998
KSEA N2O ENDOFLATOR
K980134 · KARL STORZ Endoscopy-America, Inc.
HIF · Insufflator, Laparoscopic · 90d
Cleared Dec 19, 1997
KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES
K962985 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 505d
Cleared Dec 02, 1997
MVM 3.3 MM MICROENDOSCOPE
K973304 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 90d
Cleared Jul 24, 1997
KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES
K971518 · KARL STORZ Endoscopy-America, Inc.
HIH · Hysteroscope (and Accessories) · 90d
Cleared Jun 27, 1997
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS
K971188 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 88d
Cleared Mar 18, 1997
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K970151 · Smith & Nephew, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 62d
Cleared Jan 29, 1997
KSEA PUNCTURE CANNULA
K964379 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 86d
Cleared Dec 20, 1996
KSEA UNIMAT PLUS
K963960 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 79d
Cleared Dec 19, 1996
KSEA UNIMAT PLUS
K963949 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 78d
Cleared Dec 10, 1996
KSEA THERMOCOAGULATOR (MODEL 265100 20)
K963852 · KARL STORZ Endoscopy-America, Inc.
HGI · Electrocautery, Gynecologic (and Accessories) · 76d
Cleared Dec 06, 1996
KSEA THERMOFLATOR (MODEL 26 4320 20)
K955073 · KARL STORZ Endoscopy-America, Inc.
HIF · Insufflator, Laparoscopic · 396d
Cleared Nov 26, 1996
KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
K955756 · KARL STORZ Endoscopy-America, Inc.
HGI · Electrocautery, Gynecologic (and Accessories) · 343d
Cleared Nov 19, 1996
KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR
K962863 · KARL STORZ Endoscopy-America, Inc.
HIF · Insufflator, Laparoscopic · 119d
Cleared Nov 13, 1996
KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE
K961605 · KARL STORZ Endoscopy-America, Inc.
HIH · Hysteroscope (and Accessories) · 202d
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 Jul 17, 1996
KSEA SCALP BLOOD COLLECTION SET
K954982 · KARL STORZ Endoscopy-America, Inc.
HGK · Endoscope, Fetal Blood Sampling (and Accessories) · 260d
Cleared May 16, 1996
KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY
K950335 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 475d
Cleared Apr 11, 1996
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES
K951343 · KARL STORZ Endoscopy-America, Inc.
HET · Laparoscope, Gynecologic (and Accessories) · 384d
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

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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