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
3156 Obstetrics & Gynecology devices
Cleared
Sep 13, 2000
3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
48d
Cleared
Sep 13, 2000
COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
MQL
Media, Reproductive
40d
Cleared
Sep 08, 2000
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR
HEB
Tampon, Menstrual, Unscented
59d
Cleared
Aug 22, 2000
KSEA MONOPOLAR VAPORIZATION ELECTRODES
HIH
Hysteroscope (and Accessories)
75d
Cleared
Aug 18, 2000
REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT
HIS
Condom
315d
Cleared
Aug 18, 2000
REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT
HIS
Condom
315d
Cleared
Aug 18, 2000
REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT
HIS
Condom
315d
Cleared
Aug 14, 2000
OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS
HIS
Condom
252d
Cleared
Aug 02, 2000
WATER FOR TISSUE CULTURE, MODELS 1500
MTW
System, Water, Reproduction, Assisted, And Purification
317d
Cleared
Jul 20, 2000
MEDI-CULT UNIVERSAL IVF-MEDIUM
MQL
Media, Reproductive
463d
Cleared
Jul 07, 2000
IM-9C MICROINJECTORS
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
14d
Cleared
Jul 07, 2000
IM-9A MICROINJECTORS
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
14d
Cleared
Jul 07, 2000
IM-9B MICROINJECTORS
MQJ
Micromanipulators And Microinjectors, Assisted Reproduction
14d
Cleared
Jul 06, 2000
LOOP ELECTRODE, BALL ELECTRODE
HGI
Electrocautery, Gynecologic (and Accessories)
262d
Cleared
Jun 20, 2000
MEDI-CULT M3 MEDIUM
MQL
Media, Reproductive
428d
Cleared
Jun 20, 2000
MEDI-CULT HYALURONIDASE
MQL
Media, Reproductive
428d
Cleared
Jun 20, 2000
INSUFFLATION NEEDLE- 120MM, MODEL 900-200
HIF
Insufflator, Laparoscopic
238d
Cleared
Jun 16, 2000
PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
LKF
Cannula, Manipulator/injector, Uterine
128d
Cleared
Jun 09, 2000
MICRO-FRANCE TROCARS AND ACCESSORIES
HET
Laparoscope, Gynecologic (and Accessories)
224d
Cleared
May 26, 2000
HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
HIH
Hysteroscope (and Accessories)
88d
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
FOWLER ENDOCURETTE, MODEL CUR-XXX
HHK
Curette, Suction, Endometrial (and Accessories)
57d
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
ENDOPATH SURESEAL REDUCER CAP
HET
Laparoscope, Gynecologic (and Accessories)
29d
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