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FDA 510(k)

DVAS (DVAS-M, DVAS-W)

K-Number: K232085 · 2023-12-08

Decision Date2023-12-08
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DVAS (DVAS-M, DVAS-W) is the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K232085. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DVAS (DVAS-M, DVAS-W)?

DVAS (DVAS-M, DVAS-W) is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K232085.

When did DVAS (DVAS-M, DVAS-W) receive FDA 510(k) clearance?

DVAS (DVAS-M, DVAS-W) received FDA 510(k) clearance on 2023-12-08, under 510(k) number K232085.

Who is the listed applicant for DVAS (DVAS-M, DVAS-W)?

The FDA 510(k) record lists Genoray Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DVAS (DVAS-M, DVAS-W)?

The FDA product code for DVAS (DVAS-M, DVAS-W) is EHD.

Other records listing Genoray Co., Ltd. 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.

View all 13 devices →

Related Devices (Code: EHD)

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.

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.