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
Cleared
Dec 15, 1994
KARL STORZ INSULATED BIOPSY FORCEPS
KNF
Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
100d
Cleared
Aug 15, 1994
MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM
HGM
System, Monitoring, Perinatal
56d
Cleared
Jul 25, 1994
AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR
LKF
Cannula, Manipulator/injector, Uterine
521d
Cleared
May 27, 1994
OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT
LKF
Cannula, Manipulator/injector, Uterine
198d
Cleared
May 19, 1994
SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS
HET
Laparoscope, Gynecologic (and Accessories)
91d
Cleared
May 11, 1994
KARL STORZ IRRIGATION AND SUCTION SYSTEM HANDPIECE AND ACCESSORIES
HET
Laparoscope, Gynecologic (and Accessories)
156d
Cleared
May 10, 1994
KARL STORZ ELECTRONIC LAPAROFLATOR
HIF
Insufflator, Laparoscopic
264d
Cleared
May 10, 1994
KARL STORZ ELECTRONIC LAPAROFLATOR
HIF
Insufflator, Laparoscopic
258d
Cleared
May 10, 1994
HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION
HET
Laparoscope, Gynecologic (and Accessories)
97d
Cleared
May 06, 1994
KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS
HET
Laparoscope, Gynecologic (and Accessories)
121d
Cleared
Apr 28, 1994
ENDOSCOPE
HET
Laparoscope, Gynecologic (and Accessories)
519d
Cleared
Mar 15, 1994
MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER
HHI
System, Abortion, Vacuum
371d
Cleared
Mar 11, 1994
RETRACTORS AND SCRAPER
HET
Laparoscope, Gynecologic (and Accessories)
263d
Cleared
Feb 14, 1994
AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER
HFW
Clamp, Umbilical
150d
Cleared
Sep 24, 1993
HEWLETT PACKARD MODEL M1353A FETAL MONITOR
HGM
System, Monitoring, Perinatal
515d
Cleared
Sep 24, 1993
HEWLETT-PACKARD MODEL M1351A FETAL MONITOR
HGM
System, Monitoring, Perinatal
515d
Cleared
Jul 29, 1993
VIDEO ENDOSCOPE SYSTEM
HET
Laparoscope, Gynecologic (and Accessories)
434d
Cleared
Feb 05, 1993
DAVOL LAPAROSCOPIC DISSECTORS
HET
Laparoscope, Gynecologic (and Accessories)
385d
Cleared
Sep 29, 1992
AUTO SUTURE SURGIPORT DISPOSABLE ANCHORING DEVICE
HET
Laparoscope, Gynecologic (and Accessories)
308d
Cleared
Sep 28, 1992
CONDUCTIVE SURGIGRIP SPIRAL SLEEVE
HET
Laparoscope, Gynecologic (and Accessories)
307d
Cleared
Dec 18, 1991
THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
HIG
Insufflator, Hysteroscopic
196d
Cleared
Aug 26, 1991
AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV
HET
Laparoscope, Gynecologic (and Accessories)
174d
Cleared
Mar 04, 1991
LAPAROSCOPE
HET
Laparoscope, Gynecologic (and Accessories)
104d
Cleared
Feb 11, 1991
AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE
HET
Laparoscope, Gynecologic (and Accessories)
69d
Cleared
Feb 07, 1991
BARD UTERINE MANIPULATOR
LKF
Cannula, Manipulator/injector, Uterine
155d
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