K901107 is an FDA 510(k) clearance for the MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC. This device is classified as a Clamp, Surgical, General & Plastic Surgery (Class I - General Controls, product code GDJ).
Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on April 9, 1990, 32 days after receiving the submission on March 8, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K901107 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1990 |
| Decision Date | April 09, 1990 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDJ — Clamp, Surgical, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |