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FDA 510(k)

PuraSinus

K-Number: K183015 · 2019-04-12

Applicant3-D Matrix, Inc.
Decision Date2019-04-12
Product CodeNHB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PuraSinus is a medical device manufactured by 3-D Matrix, Inc.. It received FDA 510(k) clearance on 2019-04-12 under approval number K183015. The device is classified under product code NHB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PuraSinus?

PuraSinus is a medical device that received FDA 510(k) clearance on 2019-04-12. It is manufactured by 3-D Matrix, Inc.. The 510(k) number is K183015.

When was PuraSinus approved by the FDA?

PuraSinus received FDA 510(k) clearance on 2019-04-12, under approval number K183015.

What company makes PuraSinus?

PuraSinus is manufactured by 3-D Matrix, Inc..

What is the FDA product code for PuraSinus?

The FDA product code for PuraSinus is NHB.

Other Devices by 3-D Matrix, Inc.

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

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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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