K911829 is an FDA 510(k) clearance for the ENDOSTAPLE. This device is classified as a Laryngoscope, Endoscope (Class II - Special Controls, product code GCI).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on August 28, 1991, 126 days after receiving the submission on April 24, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K911829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 1991 |
| Decision Date | August 28, 1991 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GCI — Laryngoscope, Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |