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FDA 510(k)

NPseal

K-Number: K250708 · 2025-04-08

ApplicantGuard Medical, Inc.
Decision Date2025-04-08
Product CodeOKO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NPseal is a medical device manufactured by Guard Medical, Inc.. It received FDA 510(k) clearance on 2025-04-08 under approval number K250708. 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 2025-04-08. It is manufactured by Guard Medical, Inc.. The 510(k) number is K250708.

When was NPseal approved by the FDA?

NPseal received FDA 510(k) clearance on 2025-04-08, under approval number K250708.

What company makes NPseal?

NPseal is manufactured by Guard Medical, Inc..

What is the FDA product code for NPseal?

The FDA product code for NPseal is OKO.

Other Devices by Guard Medical, Inc.

K200305NPseal K211130NPseal K212971NPseal K241522NPseal (20 and 25) K240244NPseal (Small, Medium, Large) K251156NPseal

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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. K241522NPseal (20 and 25)Guard Medical, Inc. K240244NPseal (Small, Medium, Large)Guard 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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