Cleared Traditional

K934603 - SURGICAL SAW BLADES (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K934603 · American Medical Specialties, Inc. · General & Plastic Surgery device
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Feb 1994
Decision
151d
Days
Class 1
Risk

K934603 is an FDA 510(k) clearance for the SURGICAL SAW BLADES. Classified as Blade, Saw, General & Plastic Surgery, Surgical (product code GFA), Class I - General Controls.

Submitted by American Medical Specialties, Inc. (Roswell, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 151 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 American Medical Specialties, Inc. devices

Submission Details

510(k) Number K934603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1993
Decision Date February 22, 1994
Days to Decision 151 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 114d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GFA Blade, Saw, General & Plastic Surgery, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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.