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
3155 Obstetrics & Gynecology devices
1501–1525 of 3155
Cleared Jun 25, 2004
JOEY CLAMP OPENING TOOL
K041332 · Maternus, Inc.
HFW · Clamp, Umbilical · 37d
Cleared Jun 17, 2004
HSG CATHETER SET
K041094 · Bioteque America, Inc.
LKF · Cannula, Manipulator/injector, Uterine · 51d
Cleared May 25, 2004
SONOTRAX ULTRASONIC POCKET DOPPLER
K040480 · Edan Instruments, Inc.
KNG · Monitor, Ultrasonic, Fetal · 90d
Cleared May 17, 2004
STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
K040390 · Stryker Endoscopy
HIH · Hysteroscope (and Accessories) · 90d
Cleared May 17, 2004
AMS PERIGEE SYSTEM
K040623 · American Medical Systems, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 69d
Cleared May 07, 2004
G-OOCYTE
K032877 · Vitrolife Sweden AB
MQL · Media, Reproductive · 235d
Cleared May 07, 2004
G-PGD
K033101 · Vitrolife Sweden AB
MQL · Media, Reproductive · 221d
Cleared May 03, 2004
TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
K040312 · Procter & Gamble Co.
HIL · Tampon, Menstrual, Scented, Scented-deodorized · 84d
Cleared Apr 26, 2004
MULTIBLAST MEDIUM
K034063 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 117d
Cleared Apr 22, 2004
AMS APOGEE VAULT SUSPENSION SYSTEM
K040537 · American Medical Systems, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 51d
Cleared Mar 24, 2004
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
K040521 · American Medical Systems, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 23d
Cleared Mar 23, 2004
SYDNEY IVF PVP
K031304 · Cook Urological, Inc.
MQL · Media, Reproductive · 334d
Cleared Mar 12, 2004
IMAGE MANAGEMENT SYSTEM
K033870 · Welch Allyn, Inc.
HEX · Colposcope (and Colpomicroscope) · 91d
Cleared Mar 12, 2004
APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
K040295 · Applied Medical Resources Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 32d
Cleared Feb 27, 2004
TRANSVAGINAL ENDOSCOPY SET
K033728 · KARL STORZ Endoscopy-America, Inc.
HEW · Culdoscope (and Accessories) · 91d
Cleared Jan 16, 2004
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
K033903 · Cook Urological, Inc.
MQH · Microtools, Assisted Reproduction (pipettes) · 30d
Cleared Jan 16, 2004
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
K033904 · Cook Urological, Inc.
MQH · Microtools, Assisted Reproduction (pipettes) · 30d
Cleared Jan 15, 2004
EARLY CLEAVAGE MEDIUM (ECM)
K033462 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 76d
Cleared Dec 31, 2003
AMS LARGE PORE POLYPROPYLENE MESH
K033636 · American Medical Systems, Inc.
OTP · Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed · 42d
Cleared Dec 23, 2003
UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753
K033113 · Richard Wolf Medical Instruments Corp.
HIH · Hysteroscope (and Accessories) · 84d
Cleared Dec 19, 2003
PHENOL RED STOCK SOLUTION
K032887 · Irvine Scientific Sales Co., Inc.
MQL · Media, Reproductive · 94d
Cleared Dec 02, 2003
SMITH & NEPHEW IUR MORCELLATION SYSTEM
K031787 · Smith & Nephew, Inc.
HIH · Hysteroscope (and Accessories) · 175d
Cleared Nov 14, 2003
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
K032636 · Playtex Products, Inc.
HEB · Tampon, Menstrual, Unscented · 79d
Cleared Sep 23, 2003
CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
K030966 · Boston Scientific Corp
NAJ · Agents, Embolic, For Treatment Of Uterine Fibroids · 180d
Cleared Aug 29, 2003
SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
K030441 · Cook Ob/Gyn
MQL · Media, Reproductive · 199d

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All categories 3155 NUC Lubricant, Personal 228 HET Laparoscope, Gynecologic (and Accessories) 224 MQL Media, Reproductive 217 HGX Pump, Breast, Powered 206 HIS Condom 196 HGM System, Monitoring, Perinatal 155 HEB Tampon, Menstrual, Unscented 155 HIH Hysteroscope (and Accessories) 144 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 MQK Labware, Assisted Reproduction 43 HIG Insufflator, Hysteroscopic 43