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FDA 510(k)

PuraStat-RM

K-Number: K213552 · 2022-04-01

Applicant3-D Matrix, Inc.
Decision Date2022-04-01
Product CodePHN
DecisionSubstantially Equivalent

Device Summary

PuraStat-RM is a medical device manufactured by 3-D Matrix, Inc.. It received FDA 510(k) clearance on 2022-04-01 under approval number K213552. The device is classified under product code PHN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PuraStat-RM?

PuraStat-RM is a medical device that received FDA 510(k) clearance on 2022-04-01. It is manufactured by 3-D Matrix, Inc.. The 510(k) number is K213552.

When was PuraStat-RM approved by the FDA?

PuraStat-RM received FDA 510(k) clearance on 2022-04-01, under approval number K213552.

What company makes PuraStat-RM?

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

What is the FDA product code for PuraStat-RM?

The FDA product code for PuraStat-RM is PHN.

Other Devices by 3-D Matrix, Inc.

K183015PuraSinus K193085PuraDERM Gel K210211PuraStat-OM K210098PuraStat-GI K222481PuraStat

Related Devices (Code: PHN)

K242634PuraStat3-D Matrix Europe SAS K253923PuraStat3-D Matrix Europe SAS

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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