Clearance Summary
JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS received FDA 510(k) clearance under submission number K134047, sponsored by Integra LifeSciences Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2014-04-11.
- Submission: K134047
- Applicant / Sponsor: Integra LifeSciences Corporation
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2014-04-11
Classification & Regulation
This clearance is catalogued under FDA product code HCZ and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.