Cleared Traditional

K023643 - MACROPORE SURGICAL BARRIER FILM

K023643 is an FDA 510(k) clearance for MACROPORE SURGICAL BARRIER FILM, manufactured by Macropore Biosurgery, Inc.. The device is a Class 2 Ophthalmic device with product code MTZ cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K023643 · Macropore Biosurgery, Inc. · Ophthalmic device
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Feb 2003
Decision
114d
Days
Class 2
Risk

K023643 is an FDA 510(k) clearance for the MACROPORE SURGICAL BARRIER FILM. Classified as Wrap, Implant, Orbital (product code MTZ), Class II - Special Controls.

Submitted by Macropore Biosurgery, Inc. (San Diego, US). The FDA issued a Cleared decision on February 21, 2003 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3320 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Macropore Biosurgery, Inc. devices

FDA 510(k) Submission Details - K023643

510(k) Number K023643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2002
Decision Date February 21, 2003
Days to Decision 114 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 110d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MTZ Device Classification - Class 2, Special Controls

Product Code MTZ Wrap, Implant, Orbital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.