Cleared Traditional

K934603 - SURGICAL SAW BLADES

K934603 is an FDA 510(k) clearance for SURGICAL SAW BLADES, manufactured by American Medical Specialties, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GFA cleared through the Traditional 510(k) pathway after a 151-day FDA review.

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

FDA 510(k) Submission Details - K934603

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
36d slower than avg
Panel avg: 115d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

GFA Device Classification - Class 1, General Controls

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.

Regulatory Peers - GFA Blade, Saw, General & Plastic Surgery, Surgical

All 17
Devices cleared under the same product code (GFA) and FDA review panel - the closest regulatory comparables to K934603.
DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS
K953012 · Boston Surgical Products, Inc. · Jul 1995
SURGICAL SAW BLADES
K950403 · Transidyne General Corp. · Feb 1995
SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK
K935391 · 3M Health Care, Sarns · Feb 1994
OSCILLATING BONE SAW BLADE, 6200 SERIES
K934390 · Boehringer Laboratories · Jan 1994
INTERMEDICS ORTHOPEDICS SAW BLADE
K931210 · Intermedics Orthopedics · Nov 1993
FLUID COOLED BONE SAW BLADE, 6000 SERIES
K924953 · Boehringer Laboratories · Jan 1993