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510(k) K012769

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

K012769 is an FDA 510(k) premarket notification submitted by Macropore Biosurgery, Inc. for the device "MACROPORE ENT RECONSTRUCTION FILM". The FDA issued a decision of Substantially Equivalent on October 25, 2001. The device falls under product code NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable), a Class II device regulated under 21 CFR 874.3620. Macropore Biosurgery, Inc. has at least 10 other 510(k) clearances on record.

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)

FDA data resources