K142258 is an FDA 510(k) clearance for the PolyCatch Retrieval Device, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Medi-Globe Corporation (Tempe, US). The FDA issued a Cleared decision on September 30, 2014, 47 days after receiving the submission on August 14, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K142258 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 14, 2014 |
| Decision Date | September 30, 2014 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDI — Snare, Flexible |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4300 |