K932021 is an FDA 510(k) clearance for the ENTREE CANNULA FASCIA ANCHORS. This device is classified as a Cannula And Trocar, Suprapubic, Non-disposable (Class I - General Controls, product code FBM).
Submitted by Core Dynamics, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 11, 1994, 263 days after receiving the submission on April 23, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5090.
| 510(k) Number | K932021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 1993 |
| Decision Date | January 11, 1994 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FBM — Cannula And Trocar, Suprapubic, Non-disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5090 |