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
Mar 19, 2004
KRYO ART CONTROLLED RATE FREEZER
MQG
Accessory, Assisted Reproduction
256d
Cleared
Mar 12, 2004
IMAGE MANAGEMENT SYSTEM
HEX
Colposcope (and Colpomicroscope)
91d
Cleared
Mar 12, 2004
APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
HET
Laparoscope, Gynecologic (and Accessories)
32d
Cleared
Mar 11, 2004
POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX
HET
Laparoscope, Gynecologic (and Accessories)
162d
Cleared
Mar 11, 2004
KAEN YIH UMBILICAL CORD CLAMP
HFW
Clamp, Umbilical
91d
Cleared
Mar 09, 2004
VERSAPOINT RESECTOSCOPIC SYSTEM
HIH
Hysteroscope (and Accessories)
29d
Cleared
Mar 08, 2004
SMART KLAMP VARIOUS BY SIZE
HFX
Clamp, Circumcision
245d
Cleared
Mar 01, 2004
MODIFIED SONAMET BODY COMPOSITION ANALYZER
OAC
Plethysmograph, Air Displacement For Body Composition Analysis
189d
Cleared
Feb 27, 2004
TRANSVAGINAL ENDOSCOPY SET
HEW
Culdoscope (and Accessories)
91d
Cleared
Feb 05, 2004
40 L HIGH FLOW INSUFFLATOR F108
HIF
Insufflator, Laparoscopic
325d
Cleared
Jan 22, 2004
T.S. MEDICAL CIRCUMCISION CLAMP
HFX
Clamp, Circumcision
90d
Cleared
Jan 22, 2004
MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
HIF
Insufflator, Laparoscopic
30d
Cleared
Jan 16, 2004
DUREX PLAY LUBRICANT
HIS
Condom
190d
Cleared
Jan 16, 2004
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
MQH
Microtools, Assisted Reproduction (pipettes)
30d
Cleared
Jan 16, 2004
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
MQH
Microtools, Assisted Reproduction (pipettes)
30d
Cleared
Jan 15, 2004
EARLY CLEAVAGE MEDIUM (ECM)
MQL
Media, Reproductive
76d
Cleared
Dec 31, 2003
AMS LARGE PORE POLYPROPYLENE MESH
OTP
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
42d
Cleared
Dec 23, 2003
UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753
HIH
Hysteroscope (and Accessories)
84d
Cleared
Dec 23, 2003
LONG LOVE CONDOM
HIS
Condom
43d
Cleared
Dec 19, 2003
MEDISCOPE
HEX
Colposcope (and Colpomicroscope)
227d
Cleared
Dec 19, 2003
PHENOL RED STOCK SOLUTION
MQL
Media, Reproductive
94d
Cleared
Dec 19, 2003
LIFESTYLES LIQUID PERSONAL LUBRICANT
HIS
Condom
81d
Cleared
Dec 19, 2003
WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
MQF
Catheter, Assisted Reproduction
81d
Cleared
Dec 16, 2003
THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM
HIS
Condom
90d
Cleared
Dec 11, 2003
H/S CATHETER SET
LKF
Cannula, Manipulator/injector, Uterine
91d
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