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FDA 510(k)

MedWand

K-Number: K212975 · 2022-07-22

ApplicantMedwand Solutions, Inc.
Decision Date2022-07-22
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MedWand is the device name listed in this FDA 510(k) record. The listed applicant is Medwand Solutions, Inc.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K212975. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MedWand?

MedWand is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Medwand Solutions, Inc.. The 510(k) number is K212975.

When did MedWand receive FDA 510(k) clearance?

MedWand received FDA 510(k) clearance on 2022-07-22, under 510(k) number K212975.

Who is the listed applicant for MedWand?

The FDA 510(k) record lists Medwand Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MedWand?

The FDA product code for MedWand is MWI.

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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.

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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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