Cleared Traditional

K823901 - TREPHINE BLADES-VARIOUS MODELS (FDA 510(k) Clearance)

Class I Ophthalmic device.

K823901 · Edward Weck, Inc. · Ophthalmic device
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Jan 1983
Decision
18d
Days
Class 1
Risk

K823901 is an FDA 510(k) clearance for the TREPHINE BLADES-VARIOUS MODELS. Classified as Engine, Trephine, Accessories, Ac-powered (product code HRG), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1983 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4070 - 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 Edward Weck, Inc. devices

Submission Details

510(k) Number K823901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1982
Decision Date January 17, 1983
Days to Decision 18 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 110d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRG Engine, Trephine, Accessories, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4070
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.