Cleared Traditional

K904638 - TROCAR DISPOSABLE (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904638 · L.A.S.E.R., Inc. · General & Plastic Surgery device
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Feb 1991
Decision
133d
Days
Class 2
Risk

K904638 is an FDA 510(k) clearance for the TROCAR DISPOSABLE. Classified as Trocar, Gastro-urology (product code FBQ), Class II - Special Controls.

Submitted by L.A.S.E.R., Inc. (Tomball, US). The FDA issued a Cleared decision on February 21, 1991 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.5090 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all L.A.S.E.R., Inc. devices

Submission Details

510(k) Number K904638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1990
Decision Date February 21, 1991
Days to Decision 133 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 114d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FBQ Trocar, Gastro-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
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 General & Plastic Surgery devices follow this clearance model.