K830741 is an FDA 510(k) clearance for the PARAMETRIC STERILITY RELEASE OF AUTO. This device is classified as a Stapler, Surgical (Class II - Special Controls, product code GAG).
Submitted by United Surgical Corp. (Walker, US). The FDA issued a Cleared decision on August 11, 1983, 156 days after receiving the submission on March 8, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4740. 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..
| 510(k) Number | K830741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1983 |
| Decision Date | August 11, 1983 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAG — Stapler, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4740 |
| Definition | 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. |