K922123 is an FDA 510(k) clearance for the AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH. This device is classified as a Laryngoscope, Endoscope (Class II - Special Controls, product code GCI).
Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on February 1, 1993, 271 days after receiving the submission on May 6, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K922123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1992 |
| Decision Date | February 01, 1993 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GCI — Laryngoscope, Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |