510(k) K892927
K892927 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "PROXIMATE LINEAR CUTTER THICK TISSUE INST.". The FDA issued a decision of Substantially Equivalent on May 26, 1989. The device falls under product code GAG (Stapler, Surgical), a Class II device regulated under 21 CFR 878.4740. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1989
- Date Received
- April 21, 1989
- 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.