510(k) K062850
K062850 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS". The FDA issued a decision of Substantially Equivalent on October 23, 2006. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. 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
- October 23, 2006
- Date Received
- September 25, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type