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MedWand

by Medwand Solutions, Inc.

510(k) K212975

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212975 Date22 Jul 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MWI
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MedWand is a medical device designed for cardiovascular applications. It is intended to be used in procedures related to cardiovascular treatment and diagnosis.

The MedWand is supplied by Medwand Solutions, Inc. and has received FDA 510(k) clearance with the K number K212975. The device is regulated under the product code MWI and was reviewed by the Cardiovascular advisory committee.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the MedWand used for?

    The MedWand is a medical device specifically designed for cardiovascular applications, intended to be used in procedures related to cardiovascular treatment and diagnosis.

  • What regulatory approvals does the MedWand have?

    The MedWand has received FDA 510(k) clearance with K number K212975, classified under product code MWI, and was reviewed by the Cardiovascular advisory committee.

  • Is the MedWand a single-use or reusable device?

    The device data does not specify whether the MedWand is single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation.

  • How is the MedWand supplied?

    The MedWand is supplied by Medwand Solutions, Inc., located in Rancho Santa Margarita, CA. The specific packaging and supply details are not provided in the device data.