Cleared Traditional

K934494 - SURGITEL

K934494 is an FDA 510(k) clearance for SURGITEL, manufactured by General Scientific Corp.. The device is a Class 1 Ophthalmic device with product code HOH cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K934494 · General Scientific Corp. · Ophthalmic device
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Jan 1994
Decision
132d
Days
Class 1
Risk

K934494 is an FDA 510(k) clearance for the SURGITEL. Classified as Spectacle, Operating (loupe), Ophthalmic (product code HOH), Class I - General Controls.

Submitted by General Scientific Corp. (Ann Arbor, US). The FDA issued a Cleared decision on January 25, 1994 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4770 - 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 General Scientific Corp. devices

FDA 510(k) Submission Details - K934494

510(k) Number K934494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1993
Decision Date January 25, 1994
Days to Decision 132 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
22d slower than avg
Panel avg: 110d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

HOH Device Classification - Class 1, General Controls

Product Code HOH Spectacle, Operating (loupe), Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4770
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.