510(k) K844628
K844628 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET". The FDA issued a decision of Substantially Equivalent on December 14, 1984. The device falls under product code GAG (Stapler, Surgical), a Class II device regulated under 21 CFR 878.4740. American V. Mueller has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 1984
- Date Received
- November 27, 1984
- 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.