Cleared Traditional

K943275 - MEDPOR SURGICAL IMPLANT MATERIAL

K943275 is an FDA 510(k) clearance for MEDPOR SURGICAL IMPLANT MATERIAL, manufactured by Porex Surgical, Inc.. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K943275 · Porex Surgical, Inc. · Ophthalmic device
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Sep 1994
Decision
57d
Days
Class 2
Risk

K943275 is an FDA 510(k) clearance for the MEDPOR SURGICAL IMPLANT MATERIAL. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Porex Surgical, Inc. (Fairburn, US). The FDA issued a Cleared decision on September 2, 1994 after a review of 57 days - a notably fast clearance cycle.

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: 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 - K943275

510(k) Number K943275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1994
Decision Date September 02, 1994
Days to Decision 57 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 110d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HPZ Device Classification - Class 2, Special Controls

Product Code HPZ Implant, Eye Sphere
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.