Cleared Traditional

Wee Bell

K221356 · Wee Medical · Obstetrics & Gynecology

Feb 2023

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K221356 is an FDA 510(k) clearance for the Wee Bell, 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 review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K221356 FDA.gov
FDA Decision	Cleared 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