510(k) K926127
K926127 is an FDA 510(k) premarket notification submitted by Life Medical Sciences, Inc. for the device "SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 24, 1993. The device falls under product code GAG (Stapler, Surgical), a Class II device regulated under 21 CFR 878.4740. Life Medical Sciences, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1993
- Date Received
- December 4, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stapler, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4740
- Review Panel
- SU
- Submission Type
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.