FDA 510(k)

PuraStat

K-Number: K242250 · 2024-10-22

Decision Date2024-10-22

Product CodeQAU

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PuraStat is the device name listed in this FDA 510(k) record. The listed applicant is 3-D Matrix Europe SAS. It received FDA 510(k) clearance on 2024-10-22 under 510(k) number K242250. 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 2024-10-22. The listed applicant is 3-D Matrix Europe SAS. The 510(k) number is K242250.

When did PuraStat receive FDA 510(k) clearance?

PuraStat received FDA 510(k) clearance on 2024-10-22, under 510(k) number K242250.

Who is the listed applicant for PuraStat?

The FDA 510(k) record lists 3-D Matrix Europe SAS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PuraStat?

The FDA product code for PuraStat is QAU.

Other records listing 3-D Matrix Europe SAS 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.

K253924PuraStat K253923PuraStat K242634PuraStat

Related Devices (Code: QAU)

K261503PuraStat GI3-D Matrix, Inc.K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc.K253924PuraStat3-D Matrix Europe SAS K240994NexpowderNextbiomedical Co., Ltd.K234131Resolv Endoscopic Hemostat SystemHemostasis, LLC K222481PuraStat3-D Matrix, Inc.

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.