Product code MTZ— Ophthalmic

MACROPORE SURGICAL BARRIER FILM

Classification name: Wrap, Implant, Orbital
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Total cleared: 2
First cleared: 1997-12-16
Most recent: 2003-02-21

Market context for product code MTZ

FDA has cleared 2 devices under product code MTZ between 1997 and 2003, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20031 clearance
19971 clearance

Top applicants under product code MTZ

Macropore Biosurgery, Inc.1 clearance
Bio-Vascular, Inc.1 clearance

Recent clearances under product code MTZ

K023643 — MACROPORE SURGICAL BARRIER FILMMacropore Biosurgery, Inc.·2003-02-21
K973552 — OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAPBio-Vascular, Inc.·1997-12-16

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