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510(k) K183015

PuraSinus by 3-D Matrix, Inc. — Product Code NHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2019
Date Received
October 31, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type

Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.

Other clearances by 3-D Matrix, Inc.

  • K222481 — PuraStat (February 28, 2023)
  • K213552 — PuraStat-RM (April 1, 2022)
  • K210211 — PuraStat-OM (October 8, 2021)
  • K210098 — PuraStat-GI (June 25, 2021)
  • K193085 — PuraDERM Gel (May 11, 2020)
  • K143058 — PuraDerm Gel (February 13, 2015)

Other clearances for product code NHB

  • K251790 — SeptAlign (January 16, 2026)
  • K233569 — SeptAlign (March 22, 2024)
  • K223167 — Spirair Nasal Septal Strap (August 17, 2023)
  • K210411 — PosiSep EAR Fragmentable Ear Dressing (May 5, 2022)
  • K192661 — LATERA Absorbable Nasal Implant System (November 10, 2019)
  • K161191 — Latera Absorbable Nasal Implant (June 23, 2016)
  • K152958 — INEX Absorbable Nasal Implant (December 4, 2015)
  • K132920 — SPIROX INEX DEVICE (June 10, 2014)
  • K122434 — MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL (October 31, 2012)
  • K092590 — PDS PLATES (February 17, 2010)