FDA 510(k)

NPseal (20 and 25)

K-Number: K241522 · 2024-08-15

Decision Date2024-08-15

Product CodeOKO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NPseal (20 and 25) 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 2024-08-15 under 510(k) number K241522. 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 (20 and 25)?

NPseal (20 and 25) is a medical device that received FDA 510(k) clearance on 2024-08-15. The listed applicant is Guard Medical, Inc.. The 510(k) number is K241522.

When did NPseal (20 and 25) receive FDA 510(k) clearance?

NPseal (20 and 25) received FDA 510(k) clearance on 2024-08-15, under 510(k) number K241522.

Who is the listed applicant for NPseal (20 and 25)?

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 (20 and 25)?

The FDA product code for NPseal (20 and 25) 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.

K251156NPseal K250708NPseal K240244NPseal (Small, Medium, Large)K212971NPseal K211130NPseal K200305NPseal

View all 7 devices →

Related Devices (Code: OKO)

K251156NPsealGuard Medical, Inc.K250708NPsealGuard Medical, Inc.K240244NPseal (Small, Medium, Large)Guard Medical, Inc.K212971NPsealGuard Medical, Inc.K211130NPsealGuard Medical, Inc.K200305NPsealGuard Medical, Inc.

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.