510(k) K012769

MACROPORE ENT RECONSTRUCTION FILM by Macropore Biosurgery, Inc. — Product Code NHB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 25, 2001
Date Received: August 17, 2001
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 Macropore Biosurgery, Inc.

K042261 — MACROPORE PURICEL LIPOPLASTY SYSTEM (September 20, 2004)
K041105 — MACROPORE HYDROSORB SPINE SYSTEM (July 28, 2004)
K031955 — MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET (September 22, 2003)
K031785 — MACROPORE CARDIO-WRAP (TS) (September 4, 2003)
K024169 — MACROPORE OS RECONSTRUCTION (July 1, 2003)
K023643 — MACROPORE SURGICAL BARRIER FILM (February 21, 2003)
K021164 — MACROPORE OS TRAUMA (July 1, 2002)
K012025 — MACROPORE SURGIWRAP (TS) (December 3, 2001)
K012413 — MACROPORE FX, PS, NS, LP (September 18, 2001)
K011715 — MACROPORE IB RESORBABLE PLUG (August 27, 2001)

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)
K183015 — PuraSinus (April 12, 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)