# K221356: Wee Bell

- Pathway: 510(k) (Traditional)
- Applicant: Wee Medical
- Decided: Feb 2, 2023 after 268 days
- Product code: HFX (Clamp, Circumcision)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K032091 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151095: Circumplast Circumcision Device, Novadien Healthcare (2015) Summary page 4.

## Indications for use
The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature. The ligature is intended for use with the wee Bell Circumcision device only.

Source page: https://510kreport.com/device/K221356
Methodology: https://510kreport.com/methodology