K920752 is an FDA 510(k) clearance for the ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Ethicon, Inc. (Cincinnati, US). The FDA issued a Cleared decision on August 6, 1992, 169 days after receiving the submission on February 19, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K920752 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1992 |
| Decision Date | August 06, 1992 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDW — Staple, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4750 |