Cleared Traditional

K935391 - SARNS STERNAL SAW II

K935391 is an FDA 510(k) clearance for SARNS STERNAL SAW II, manufactured by 3M Health Care, Sarns. The device is a Class 1 General & Plastic Surgery device with product code GFA cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K935391 · 3M Health Care, Sarns · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
108d
Days
Class 1
Risk

K935391 is an FDA 510(k) clearance for the SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK.... Classified as Blade, Saw, General & Plastic Surgery, Surgical (product code GFA), Class I - General Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on February 24, 1994 after a review of 108 days - within the typical 510(k) review window.

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 3M Health Care, Sarns devices

FDA 510(k) Submission Details - K935391

510(k) Number K935391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1993
Decision Date February 24, 1994
Days to Decision 108 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 115d · This submission: 108d
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

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