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FDA 510(k)

NPseal

K-Number: K200305 · 2020-05-26

Decision Date2020-05-26
Product CodeOKO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NPseal is the device name listed in this FDA 510(k) record. The listed applicant is Guard Medical, Inc.. It received FDA 510(k) clearance on 2020-05-26 under 510(k) number K200305. The device is classified under product code OKO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NPseal?

NPseal is a medical device that received FDA 510(k) clearance on 2020-05-26. The listed applicant is Guard Medical, Inc.. The 510(k) number is K200305.

When did NPseal receive FDA 510(k) clearance?

NPseal received FDA 510(k) clearance on 2020-05-26, under 510(k) number K200305.

Who is the listed applicant for NPseal?

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

What is the FDA product code for NPseal?

The FDA product code for NPseal is OKO.

Other records listing Guard Medical, Inc. 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 7 devices →

Related Devices (Code: OKO)

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

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