Cleared Traditional

HEDGES CORNEAL WETTING PAK (K970161) - FDA 510(k) Clearance

Class I Ophthalmic device.

K970161 · Hedges Cwp, Inc. · Ophthalmic device
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Mar 1997
Decision
70d
Days
Class 1
Risk

K970161 is an FDA 510(k) clearance for the HEDGES CORNEAL WETTING PAK. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Hedges Cwp, Inc. (Cherry Hill, US). The FDA issued a Cleared decision on March 25, 1997 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4360 - 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 Hedges Cwp, Inc. devices

Submission Details

510(k) Number K970161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1997
Decision Date March 25, 1997
Days to Decision 70 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
40d faster than avg
Panel avg: 110d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYG Device, Irrigation, Ocular Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4360
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.