FDA 510(k)

PuraStat-RM

K-Number: K261504 · 2026-08-03

Decision Date2026-08-03

Product CodePHN

DecisionSubstantially Equivalent

Device Summary

PuraStat-RM 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 2026-08-03 under 510(k) number K261504. 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 2026-08-03. The listed applicant is 3-D Matrix, Inc.. The 510(k) number is K261504.

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

PuraStat-RM received FDA 510(k) clearance on 2026-08-03, under 510(k) number K261504.

Who is the listed applicant for PuraStat-RM?

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-RM?

The FDA product code for PuraStat-RM is PHN.

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.

K261503PuraStat GI K222481PuraStat K213552PuraStat-RM K210211PuraStat-OM K210098PuraStat-GI K193085PuraDERM Gel

View all 8 devices →

Related Devices (Code: PHN)

K253923PuraStat3-D Matrix Europe SAS K242634PuraStat3-D Matrix Europe SAS K213552PuraStat-RM3-D Matrix, Inc.

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.