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FDA 510(k)

PuraStat-GI

K-Number: K210098 · 2021-06-25

Applicant3-D Matrix, Inc.
Decision Date2021-06-25
Product CodeQAU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PuraStat-GI is a medical device manufactured by 3-D Matrix, Inc.. It received FDA 510(k) clearance on 2021-06-25 under approval 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. It is manufactured by 3-D Matrix, Inc.. The 510(k) number is K210098.

When was PuraStat-GI approved by the FDA?

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

What company makes PuraStat-GI?

PuraStat-GI is manufactured by 3-D Matrix, Inc..

What is the FDA product code for PuraStat-GI?

The FDA product code for PuraStat-GI is QAU.

Other Devices by 3-D Matrix, Inc.

K183015PuraSinus K193085PuraDERM Gel K210211PuraStat-OM K213552PuraStat-RM K222481PuraStat

Related Devices (Code: QAU)

DEN170015Hemospray Endoscopic HemostatWilson-Cook Medical, Inc. K200972Hemospray Endoscopic HemostatWilson-Cook Medical, Inc. K190677EndoClotEndoclot Plus Co., Ltd. K202929NexpowderNextbiomedical Co., Ltd. K222481PuraStat3-D Matrix, Inc. K240994NexpowderNextbiomedical Co., Ltd.

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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