K031758 is an FDA 510(k) clearance for the ACMI M4 TELESCOPES, a Telescope, Rigid, Endoscopic (Class II — Special Controls, product code FBP), submitted by Acmi Corporation (Southborough, US). The FDA issued a Cleared decision on September 2, 2003, 88 days after receiving the submission on June 6, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K031758 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 06, 2003 |
| Decision Date | September 02, 2003 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FBP — Telescope, Rigid, Endoscopic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |