510(k) K071920
K071920 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "AUTOSUTURE ABSORBABLE TACK AND APPLICATOR". The FDA issued a decision of Substantially Equivalent on September 28, 2007. 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
- September 28, 2007
- Date Received
- July 12, 2007
- Clearance Type
- Traditional
- 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