PuraSinus— 510(k) K183015

Substantially Equivalent

3-D Matrix, Inc.

FDA 510(k) clearance K183015 for PuraSinus, Substantially Equivalent on 2019-04-12. Applicant: 3-D Matrix, Inc.. Device class: 2.

Clearance details

Applicant: 3-D Matrix, Inc.
Product code: Code NHB
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2018-10-31
Decision date: 2019-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from 3-D Matrix, Inc.

Recalls naming K183015

K-number listed on FDA's recall record

Z-0744-2022 — PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006Class II·Terminated·3-D Matrix, Inc.·20191202

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183015.

Data sourced from openFDA. This site is unofficial and independent of the FDA.