Cleared Traditional

K952677 - MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL

K952677 is an FDA 510(k) clearance for MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL, manufactured by Porex Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FWP cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K952677 · Porex Surgical, Inc. · General & Plastic Surgery device
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Aug 1995
Decision
70d
Days
Class 2
Risk

K952677 is an FDA 510(k) clearance for the MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL. Classified as Prosthesis, Chin, Internal (product code FWP), Class II - Special Controls.

Submitted by Porex Surgical, Inc. (College Park, US). The FDA issued a Cleared decision on August 21, 1995 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3550 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Porex Surgical, Inc. devices

FDA 510(k) Submission Details - K952677

510(k) Number K952677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1995
Decision Date August 21, 1995
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FWP Device Classification - Class 2, Special Controls

Product Code FWP Prosthesis, Chin, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3550
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FWP Prosthesis, Chin, Internal

All 28
Devices cleared under the same product code (FWP) and FDA review panel - the closest regulatory comparables to K952677.
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