510(k) K134047
K134047 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS". The FDA issued a decision of Substantially Equivalent on April 11, 2014. The device falls under product code HCZ (Forceps, Surgical, Gynecological), a Class II device regulated under 21 CFR 884.4530. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2014
- Date Received
- December 31, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Surgical, Gynecological
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type