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FDA 510(k)

PuraStat

K-Number: K253924 · 2026-01-07

Applicant3-D Matrix Europe SAS
Decision Date2026-01-07
Product CodeQAU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PuraStat is a medical device manufactured by 3-D Matrix Europe SAS. It received FDA 510(k) clearance on 2026-01-07 under approval number K253924. The device is classified under product code QAU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PuraStat?

PuraStat is a medical device that received FDA 510(k) clearance on 2026-01-07. It is manufactured by 3-D Matrix Europe SAS. The 510(k) number is K253924.

When was PuraStat approved by the FDA?

PuraStat received FDA 510(k) clearance on 2026-01-07, under approval number K253924.

What company makes PuraStat?

PuraStat is manufactured by 3-D Matrix Europe SAS.

What is the FDA product code for PuraStat?

The FDA product code for PuraStat is QAU.

Other Devices by 3-D Matrix Europe SAS

K242250PuraStat K242634PuraStat K253923PuraStat

Related Devices (Code: QAU)

DEN170015Hemospray Endoscopic HemostatWilson-Cook Medical, Inc. K200972Hemospray Endoscopic HemostatWilson-Cook Medical, Inc. K210098PuraStat-GI3-D Matrix, Inc. K190677EndoClotEndoclot Plus Co., Ltd. K202929NexpowderNextbiomedical Co., Ltd. K222481PuraStat3-D Matrix, 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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