Wee Bell— 510(k) K221356

Substantially Equivalent

Wee Medical

FDA 510(k) clearance K221356 for Wee Bell, Substantially Equivalent on 2023-02-02. Applicant: Wee Medical.

Clearance details

Applicant: Wee Medical
Product code: Code HFX
Advisory panel: Obstetrics/Gynecology
Date received: 2022-05-10
Decision date: 2023-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HFX

product code HFX

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.