K213222 is an FDA 510(k) clearance for the Disposable Polypectomy Snare, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Beijing Zksk Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on June 6, 2022, 250 days after receiving the submission on September 29, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K213222 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2021 |
| Decision Date | June 06, 2022 |
| Days to Decision | 250 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 |