K890818 is an FDA 510(k) clearance for the AUTO SUTURE DISPOSABLE SURGICAL TROCAR*. This device is classified as a Cutter, Surgical (Class I - General Controls, product code FZT).
Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on May 4, 1989, 76 days after receiving the submission on February 17, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K890818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 1989 |
| Decision Date | May 04, 1989 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZT — Cutter, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |