K900955 is an FDA 510(k) clearance for the GS-4000 REDUCER SLEEVE, 11MM TO 5MM. This device is classified as a Cannula And Trocar, Suprapubic, Non-disposable (Class I - General Controls, product code FBM).
Submitted by Solos Endoscopy, Inc. (Norcross, US). The FDA issued a Cleared decision on April 18, 1990, 50 days after receiving the submission on February 27, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5090.
| 510(k) Number | K900955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1990 |
| Decision Date | April 18, 1990 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FBM — Cannula And Trocar, Suprapubic, Non-disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5090 |