Cleared Traditional

ETO METHOD - STERILIZE INTRAOCULAR LENS (K761178) - FDA 510(k) Clearance

K761178 · Medical Workshop · Ophthalmic device
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Dec 1976
Decision
13d
Days
-
Risk

K761178 is an FDA 510(k) clearance for the ETO METHOD - STERILIZE INTRAOCULAR LENS.

Submitted by Medical Workshop (Mchenry, US). The FDA issued a Cleared decision on December 15, 1976 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. 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.

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Submission Details

510(k) Number K761178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1976
Decision Date December 15, 1976
Days to Decision 13 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 110d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -