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FDA 510(k)

Wee Bell

K-Number: K221356 · 2023-02-02

ApplicantWee Medical
Decision Date2023-02-02
Product CodeHFX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Wee Bell is the device name listed in this FDA 510(k) record. The listed applicant is Wee Medical. It received FDA 510(k) clearance on 2023-02-02 under 510(k) number K221356. The device is classified under product code HFX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wee Bell?

Wee Bell is a medical device that received FDA 510(k) clearance on 2023-02-02. The listed applicant is Wee Medical. The 510(k) number is K221356.

When did Wee Bell receive FDA 510(k) clearance?

Wee Bell received FDA 510(k) clearance on 2023-02-02, under 510(k) number K221356.

Who is the listed applicant for Wee Bell?

The FDA 510(k) record lists Wee Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wee Bell?

The FDA product code for Wee Bell is HFX.

Related Devices (Code: HFX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251687Konig Bell Circumcision ClampMedline Industries, LPK212911Konig Mogen ClampMedline Industries, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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