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FDA 510(k)

NPseal (20 and 25)

K-Number: K241522 · 2024-08-15

ApplicantGuard Medical, Inc.
Decision Date2024-08-15
Product CodeOKO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NPseal (20 and 25) is a medical device manufactured by Guard Medical, Inc.. It received FDA 510(k) clearance on 2024-08-15 under approval 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. It is manufactured by Guard Medical, Inc.. The 510(k) number is K241522.

When was NPseal (20 and 25) approved by the FDA?

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

What company makes NPseal (20 and 25)?

NPseal (20 and 25) is manufactured by Guard Medical, Inc..

What is the FDA product code for NPseal (20 and 25)?

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

Other Devices by Guard Medical, Inc.

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

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Related Devices (Code: OKO)

K200305NPsealGuard Medical, Inc. K193185Anscare SIMO Negative Pressure Wound Therapy (NPWT) SystemBenq Materials Corporation K211130NPsealGuard Medical, Inc. K212971NPsealGuard Medical, Inc. K240244NPseal (Small, Medium, Large)Guard Medical, Inc. K251156NPsealGuard 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.

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