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
851–875 of 1727
Cleared Sep 02, 2004
CADENCE, MODELS 2001 AND 2002
K040903 · Edan Instruments, Inc.
HGM · System, Monitoring, Perinatal · 148d
Cleared Aug 09, 2004
CRYOTIP
K041562 · Irvine Scientific Sales Co., Inc.
MQH · Microtools, Assisted Reproduction (pipettes) · 60d
Cleared Jul 29, 2004
MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
K033614 · Northgate Technologies, Inc.
HIF · Insufflator, Laparoscopic · 255d
Cleared Jul 09, 2004
VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM
K041321 · Richard Wolf Medical Instruments Corp.
HET · Laparoscope, Gynecologic (and Accessories) · 52d
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 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 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 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 HIL Tampon, Menstrual, Scented, Scented-deodorized 24 MQF Catheter, Assisted Reproduction 24