K033591 is an FDA 510(k) clearance for the REPROCESSED TROCARS. This device is classified as a Trocar, Sinus (Class I - General Controls, product code KBG).
Submitted by Clearmedical, Inc. (Bellevue, US). The FDA issued a Cleared decision on June 3, 2005, 568 days after receiving the submission on November 13, 2003.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.
| 510(k) Number | K033591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2003 |
| Decision Date | June 03, 2005 |
| Days to Decision | 568 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | KBG — Trocar, Sinus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4420 |