FDA 510(k)

Vesseal

K-Number: K221280 · 2022-12-09

Decision Date2022-12-09

Product CodeGAW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Vesseal is the device name listed in this FDA 510(k) record. The listed applicant is Lydus Medical , Ltd.. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K221280. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vesseal?

Vesseal is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Lydus Medical , Ltd.. The 510(k) number is K221280.

When did Vesseal receive FDA 510(k) clearance?

Vesseal received FDA 510(k) clearance on 2022-12-09, under 510(k) number K221280.

Who is the listed applicant for Vesseal?

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

What is the FDA product code for Vesseal?

The FDA product code for Vesseal is GAW.

Related Devices (Code: GAW)

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.