FDA 510(k)

PuraStat-OM

K-Number: K210211 · 2021-10-08

Decision Date2021-10-08

Product CodeOLR

DecisionSubstantially Equivalent

Device Summary

PuraStat-OM 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 2021-10-08 under 510(k) number K210211. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PuraStat-OM?

PuraStat-OM is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is 3-D Matrix, Inc.. The 510(k) number is K210211.

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

PuraStat-OM received FDA 510(k) clearance on 2021-10-08, under 510(k) number K210211.

Who is the listed applicant for PuraStat-OM?

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-OM?

The FDA product code for PuraStat-OM is OLR.

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 K210098PuraStat-GI K193085PuraDERM Gel

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K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLC K251908Emanate TrayEmanate Biomedical K260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, 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.