510(k) K061288
K061288 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER". The FDA issued a decision of Substantially Equivalent on November 2, 2006. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. United States Surgical, A Division of Tyco Healthc has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 2006
- Date Received
- May 9, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type