FDA 510(k)

PuraStat GI

K-Number: K261503 · 2026-08-03

Decision Date2026-08-03

Product CodeQAU

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PuraStat GI is the device name listed in this FDA 510(k) record. The listed applicant is 3-D Matrix, Inc.. It received FDA 510(k) clearance on 2026-08-03 under 510(k) number K261503. 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 GI?

PuraStat GI is a medical device that received FDA 510(k) clearance on 2026-08-03. The listed applicant is 3-D Matrix, Inc.. The 510(k) number is K261503.

When did PuraStat GI receive FDA 510(k) clearance?

PuraStat GI received FDA 510(k) clearance on 2026-08-03, under 510(k) number K261503.

Who is the listed applicant for PuraStat GI?

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

What is the FDA product code for PuraStat GI?

The FDA product code for PuraStat GI is QAU.

Other records listing 3-D Matrix, 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.

K261504PuraStat-RM K222481PuraStat K213552PuraStat-RM K210211PuraStat-OM K210098PuraStat-GI K193085PuraDERM Gel

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Related Devices (Code: QAU)

K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc.K253924PuraStat3-D Matrix Europe SAS K240994NexpowderNextbiomedical Co., Ltd.K242250PuraStat3-D Matrix Europe SAS K234131Resolv Endoscopic Hemostat SystemHemostasis, LLC 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.