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
3153 Obstetrics & Gynecology devices
Cleared
Jan 11, 2008
MODIFICATION TO: ARAGON SURGICAL LAPCAP
HIF
Insufflator, Laparoscopic
32d
Cleared
Dec 20, 2007
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
HGM
System, Monitoring, Perinatal
56d
Cleared
Dec 19, 2007
PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
62d
Cleared
Dec 13, 2007
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
HIF
Insufflator, Laparoscopic
267d
Cleared
Dec 12, 2007
K-Y BRAND INTRIGUE INTENSE WARMING SENSATION
NUC
Lubricant, Personal
112d
Cleared
Dec 12, 2007
PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
110d
Cleared
Nov 28, 2007
GYN DISPOSABLES TENACULUM 356T
HDC
Tenaculum, Uterine
15d
Cleared
Nov 16, 2007
FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM
HIH
Hysteroscope (and Accessories)
207d
Cleared
Nov 15, 2007
UNIDUS MAGNUM MALE LATEX CONDOM
HIS
Condom
49d
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
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