510(k) K034029
K034029 is an FDA 510(k) premarket notification submitted by Gyrx, LLC for the device "TI CLIP APPLIER". The FDA issued a decision of Substantially Equivalent on March 5, 2004. The device falls under product code NJC (Clip, Vas Deferens), a Class II device regulated under 21 CFR 878.4300. Gyrx, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2004
- Date Received
- December 29, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Vas Deferens
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type
This is an implantable clip intended to ligate the vas deferens. This is more specific than the regulation.