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
Nov 15, 2007
COLPO-MASTER
HEX
Colposcope (and Colpomicroscope)
16d
Cleared
Nov 09, 2007
TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT
HIS
Condom
15d
Cleared
Nov 08, 2007
PINNACLE PELVIC FLOOR REPAIR KITS
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
115d
Cleared
Oct 30, 2007
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
KNF
Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
271d
Cleared
Oct 26, 2007
TROJAN-ENZ BRAND
HIS
Condom
169d
Cleared
Oct 12, 2007
SOUNMED COLOPOSCOPE COLPO-99/99PLUS
HEX
Colposcope (and Colpomicroscope)
199d
Cleared
Oct 09, 2007
PROBE HOLDER SYSTEM
LKF
Cannula, Manipulator/injector, Uterine
141d
Cleared
Oct 05, 2007
VCARE RETRACTOR/ELEVATOR
LKF
Cannula, Manipulator/injector, Uterine
87d
Cleared
Sep 27, 2007
PHILIPS AVALON FETAL MONITORS FM20 AND FM30
HGM
System, Monitoring, Perinatal
87d
Cleared
Sep 21, 2007
MULTIPLE BRAND MALE LATEX CONDOM
HIS
Condom
170d
Cleared
Sep 20, 2007
GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE
HFX
Clamp, Circumcision
472d
Cleared
Sep 20, 2007
ALWAYS MENSTRUAL PADS
HHD
Pad, Menstrual, Unscented
79d
Cleared
Sep 12, 2007
TROJAN THINTENSITY BRAND MALE LATEX CONDOM
HIS
Condom
128d
Cleared
Aug 31, 2007
PHARMAPAC LUBRICATING JELLY
NUC
Lubricant, Personal
178d
Cleared
Aug 16, 2007
VITRIFREEZE MEDIUM
MQL
Media, Reproductive
212d
Cleared
Jul 27, 2007
ENDOCERVICAL ELECTRODE # 2
HGI
Electrocautery, Gynecologic (and Accessories)
120d
Cleared
Jul 17, 2007
DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400
HGX
Pump, Breast, Powered
152d
Cleared
Jul 03, 2007
LG SPERM FREEZING
MQL
Media, Reproductive
112d
Cleared
May 30, 2007
ARAGON SURGICAL LAPCAP
HIF
Insufflator, Laparoscopic
82d
Cleared
May 23, 2007
45L CORE INSUFFLATOR, MODEL F114
HIF
Insufflator, Laparoscopic
197d
Cleared
May 23, 2007
SALINE/ CONTRAST MEDIA INFUSION CATHETER
LKF
Cannula, Manipulator/injector, Uterine
171d
Cleared
May 18, 2007
FEMTEN CERVICAL TENACULUM
HDC
Tenaculum, Uterine
260d
Cleared
May 18, 2007
NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
MQK
Labware, Assisted Reproduction
134d
Cleared
May 18, 2007
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
HIB
Speculum, Vaginal, Nonmetal
43d
Cleared
May 08, 2007
MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)
HIS
Condom
43d
Looking for a specific obstetrics & gynecology device? Search by device name, K-number or manufacturer.
Search all Obstetrics & Gynecology 510(k) devices