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
4525
Total
4511
Cleared
167d
Avg (2y)
1976
Since
4525 Obstetrics & Gynecology devices
Cleared
Jun 08, 2000
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
LTZ
Condom With Nonoxynol-9
38d
Cleared
May 26, 2000
HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
HIH
Hysteroscope (and Accessories)
88d
Cleared
May 25, 2000
IVC TWO MEDIUM
MQL
Media, Reproductive
63d
Cleared
May 25, 2000
IVC ONE MEDIUM
MQL
Media, Reproductive
63d
Cleared
May 25, 2000
Q-HTF, CAT# 2001
MQL
Media, Reproductive
224d
Cleared
May 25, 2000
DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
HGI
Electrocautery, Gynecologic (and Accessories)
199d
Cleared
May 23, 2000
SCANDINAVIAN IVF SCIENCES AB, G1.2
MQL
Media, Reproductive
96d
Cleared
May 23, 2000
SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
MQL
Media, Reproductive
96d
Cleared
May 23, 2000
FOWLER ENDOCURETTE, MODEL CUR-XXX
HHK
Curette, Suction, Endometrial (and Accessories)
57d
Cleared
May 19, 2000
ROVERS ENDOCERVEX-BRUSH
HHT
Spatula, Cervical, Cytological
42d
Cleared
May 19, 2000
MALE LATEX COMDOM WITH DOTTED SURFACE
HIS
Condom
32d
Cleared
May 17, 2000
SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
MQL
Media, Reproductive
90d
Cleared
May 17, 2000
ULTRA CATHETER SET
LKF
Cannula, Manipulator/injector, Uterine
41d
Cleared
May 17, 2000
IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500
MQL
Media, Reproductive
394d
Cleared
May 16, 2000
SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100
MQL
Media, Reproductive
89d
Cleared
May 16, 2000
SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1
MQL
Media, Reproductive
89d
Cleared
May 16, 2000
ENDOPATH SURESEAL REDUCER CAP
HET
Laparoscope, Gynecologic (and Accessories)
29d
Cleared
May 16, 2000
THE STRIPPER
MQH
Microtools, Assisted Reproduction (pipettes)
196d
Cleared
May 12, 2000
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
MQK
Labware, Assisted Reproduction
51d
Cleared
May 12, 2000
EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
MQF
Catheter, Assisted Reproduction
50d
Cleared
May 09, 2000
TROJAN EXTRA LARGE LATEX CONDOM
HIS
Condom
25d
Cleared
May 09, 2000
MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015)
MQL
Media, Reproductive
391d
Cleared
May 09, 2000
MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079
MQL
Media, Reproductive
391d
Cleared
May 04, 2000
HTF-HEPES
MQL
Media, Reproductive
42d
Cleared
May 04, 2000
HUMAN SERUM ALBUMIN (HSA)
MQL
Media, Reproductive
42d
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