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510(k) K213552

PuraStat-RM by 3-D Matrix, Inc. — Product Code PHN

K213552 is an FDA 510(k) premarket notification submitted by 3-D Matrix, Inc. for the device "PuraStat-RM". The FDA issued a decision of Substantially Equivalent on April 1, 2022. The device falls under product code PHN (Protective Coating, Mucoadhesive Application, For The Rectal Mucosa), a Class U device. 3-D Matrix, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2022
Date Received
November 8, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Mucoadhesive application for the protective coating of the rectal mucosa.

Other clearances by 3-D Matrix, Inc.

  • K222481 — PuraStat (February 28, 2023)
  • K210211 — PuraStat-OM (October 8, 2021)
  • K210098 — PuraStat-GI (June 25, 2021)
  • K193085 — PuraDERM Gel (May 11, 2020)
  • K183015 — PuraSinus (April 12, 2019)
  • K143058 — PuraDerm Gel (February 13, 2015)

Other clearances for product code PHN

  • K253923 — PuraStat (January 7, 2026)
  • K242634 — PuraStat (January 15, 2025)
  • K140558 — PROCTIGARD (July 16, 2014)

FDA data resources