Cleared Traditional

K934834 - EPTFE SHEET COVERING FOR OCULAR IMPLANT

K934834 is an FDA 510(k) clearance for EPTFE SHEET COVERING FOR OCULAR IMPLANT, manufactured by Oculo Plastik, Inc.. The device is a Class 2 Ophthalmic device with product code HPZ cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K934834 · Oculo Plastik, Inc. · Ophthalmic device
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May 1994
Decision
209d
Days
Class 2
Risk

K934834 is an FDA 510(k) clearance for the EPTFE SHEET COVERING FOR OCULAR IMPLANT. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Oculo Plastik, Inc. (Montreal, Quebec Canada, CA). The FDA issued a Cleared decision on May 5, 1994 after a review of 209 days - an extended review 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: 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 Oculo Plastik, Inc. devices

FDA 510(k) Submission Details - K934834

510(k) Number K934834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1993
Decision Date May 05, 1994
Days to Decision 209 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
99d slower than avg
Panel avg: 110d · This submission: 209d
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.

Regulatory Peers - HPZ Implant, Eye Sphere

All 17
Devices cleared under the same product code (HPZ) and FDA review panel - the closest regulatory comparables to K934834.
MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES
K960859 · Porex Technologies Corp. of Georgia · May 1996
MEDPOR OCULAR SCREW & ACCESSORIES
K954939 · Porex Surgical, Inc. · Jan 1996
MEDPOR SURGICAL IMPLANT MATERIAL
K943275 · Porex Surgical, Inc. · Sep 1994
STERILE/SINGLE USE EYE SPHERE IMPLANTS
K921106 · Storz Instrument Co. · Mar 1992