FDA 510(k)

PuraStat-GI

K-Number: K210098 · 2021-06-25

Decision Date2021-06-25

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 2021-06-25 under 510(k) number K210098. 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 2021-06-25. The listed applicant is 3-D Matrix, Inc.. The 510(k) number is K210098.

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

PuraStat-GI received FDA 510(k) clearance on 2021-06-25, under 510(k) number K210098.

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 K261503PuraStat GI K222481PuraStat K213552PuraStat-RM K210211PuraStat-OM K193085PuraDERM Gel

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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.K242250PuraStat3-D Matrix Europe SAS K234131Resolv Endoscopic Hemostat SystemHemostasis, LLC

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.