K221356 is an FDA 510(k) clearance for the Wee Bell. This device is classified as a Clamp, Circumcision (Class II - Special Controls, product code HFX).
Submitted by Wee Medical (Knoxville, US). The FDA issued a Cleared decision on February 2, 2023, 268 days after receiving the submission on May 10, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K221356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2022 |
| Decision Date | February 02, 2023 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFX - Clamp, Circumcision |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |