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
3165 Obstetrics & Gynecology devices
Cleared
Jun 27, 1994
O.B. TAMPON
HEB
Tampon, Menstrual, Unscented
73d
Cleared
Jun 24, 1994
STOVALL ENDOMETRIAL BRUSH
HFE
Brush, Endometrial
1170d
Cleared
Jun 21, 1994
ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)
HET
Laparoscope, Gynecologic (and Accessories)
138d
Cleared
Jun 14, 1994
MX4042/MC4044 SERIES SIMULCATH(TM)
KXO
Monitor, Pressure, Intrauterine
771d
Cleared
Jun 14, 1994
CONTINUOUS FLOW HYSTERO-RESECTOSCOPE
HIH
Hysteroscope (and Accessories)
754d
Cleared
Jun 14, 1994
DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE
HET
Laparoscope, Gynecologic (and Accessories)
88d
Cleared
Jun 09, 1994
LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT CURVED
HET
Laparoscope, Gynecologic (and Accessories)
707d
Cleared
Jun 08, 1994
HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES
HIH
Hysteroscope (and Accessories)
426d
Cleared
Jun 07, 1994
SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE
HFI
Coagulator, Culdoscopic (and Accessories)
560d
Cleared
Jun 07, 1994
FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE
HFI
Coagulator, Culdoscopic (and Accessories)
560d
Cleared
May 27, 1994
OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT
LKF
Cannula, Manipulator/injector, Uterine
198d
Cleared
May 26, 1994
INSITE MODEL 20 & MODEL 15 INSUFFLATORS
HIF
Insufflator, Laparoscopic
224d
Cleared
May 26, 1994
INSITE FILTER & TUBING SET
HIF
Insufflator, Laparoscopic
224d
Cleared
May 19, 1994
SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS
HET
Laparoscope, Gynecologic (and Accessories)
91d
Cleared
May 16, 1994
CABOT MEDICAL UTERINE RESECTOSCOPE
HIH
Hysteroscope (and Accessories)
609d
Cleared
May 12, 1994
PEARL PACKING FORCEPS
HCZ
Forceps, Surgical, Gynecological
43d
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
May 02, 1994
CIRCUMCISION TRAY
HFX
Clamp, Circumcision
153d
Cleared
May 02, 1994
MYOMA DRILL 5MM-8383.611
HET
Laparoscope, Gynecologic (and Accessories)
68d
Cleared
Apr 28, 1994
ENDOSCOPE
HET
Laparoscope, Gynecologic (and Accessories)
519d
Cleared
Apr 19, 1994
INSEMI-CATH
MFD
Cannula, Intrauterine Insemination
382d
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