510(k) K834138
K834138 is an FDA 510(k) premarket notification submitted by Medical Design & Manufacturing Corp. for the device "HYPO SUTURE". The FDA issued a decision of Substantially Equivalent on January 27, 1984. The device falls under product code GAG (Stapler, Surgical), a Class II device regulated under 21 CFR 878.4740. Medical Design & Manufacturing Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1984
- Date Received
- November 30, 1983
- 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.