Cleared Traditional

K943932 - STERISEAL OPHTHALMIC CANNULA

K943932 is an FDA 510(k) clearance for STERISEAL OPHTHALMIC CANNULA, manufactured by Pharma-Plast, Ltd.. The device is a Class 1 Ophthalmic device with product code HMX cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K943932 · Pharma-Plast, Ltd. · Ophthalmic device
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Jan 1995
Decision
159d
Days
Class 1
Risk

K943932 is an FDA 510(k) clearance for the STERISEAL OPHTHALMIC CANNULA. Classified as Cannula, Ophthalmic (product code HMX), Class I - General Controls.

Submitted by Pharma-Plast, Ltd. (Redditch, Worcestershire, GB). The FDA issued a Cleared decision on January 18, 1995 after a review of 159 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 Pharma-Plast, Ltd. devices

FDA 510(k) Submission Details - K943932

510(k) Number K943932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1994
Decision Date January 18, 1995
Days to Decision 159 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
49d slower than avg
Panel avg: 110d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

HMX Device Classification - Class 1, General Controls

Product Code HMX Cannula, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HMX Cannula, Ophthalmic

All 49
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