Cleared Traditional

AMER. SURGICAL CORP. EXTRA PLUS PAK (K841738) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K841738 · American Surgical Co., Inc. · Ophthalmic device
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Oct 1984
Decision
161d
Days
Class 2
Risk

K841738 is an FDA 510(k) clearance for the AMER. SURGICAL CORP. EXTRA PLUS PAK. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by American Surgical Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 5, 1984 after a review of 161 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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 American Surgical Co., Inc. devices

Submission Details

510(k) Number K841738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1984
Decision Date October 05, 1984
Days to Decision 161 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 110d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.