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FDA 510(k)

BioWave BioWraps

K-Number: K261522 · 2026-06-03

ApplicantBiowave Corporation
Decision Date2026-06-03
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BioWave BioWraps is the device name listed in this FDA 510(k) record. The listed applicant is Biowave Corporation. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K261522. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioWave BioWraps?

BioWave BioWraps is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Biowave Corporation. The 510(k) number is K261522.

When did BioWave BioWraps receive FDA 510(k) clearance?

BioWave BioWraps received FDA 510(k) clearance on 2026-06-03, under 510(k) number K261522.

Who is the listed applicant for BioWave BioWraps?

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

What is the FDA product code for BioWave BioWraps?

The FDA product code for BioWave BioWraps is GXY.

Other records listing Biowave Corporation as applicant

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.

K203158BioWave BioWrapsK210202BioWaveGO RXK180943BioWaveGO

Related Devices (Code: GXY)

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

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

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