Cleared Traditional

K924953 - FLUID COOLED BONE SAW BLADE

K924953 is the FDA 510(k) clearance for FLUID COOLED BONE SAW BLADE by Boehringer Laboratories. It is a Class 1 General & Plastic Surgery device (product code GFA) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K924953 · Boehringer Laboratories · General & Plastic Surgery device
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Jan 1993
Decision
113d
Days
Class 1
Risk

K924953 is an FDA 510(k) clearance for the FLUID COOLED BONE SAW BLADE, 6000 SERIES. Classified as Blade, Saw, General & Plastic Surgery, Surgical (product code GFA), Class I - General Controls.

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on January 21, 1993 after a review of 113 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 Boehringer Laboratories devices

Submission Details

510(k) Number K924953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1992
Decision Date January 21, 1993
Days to Decision 113 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 115d · This submission: 113d
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.

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

All 11
Devices cleared under the same product code (GFA) and FDA review panel - the closest regulatory comparables to K924953.
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
MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50
K896280 · Micro-Aire Surgical Instruments, Inc. · Nov 1989
MICRO-AIRE REPLACEMENT SURG. SAW BLADE
K831714 · Micro-Aire Surgical Instruments, Inc. · Jul 1983
DISPOSABLE INTRA-ARTICULAR BLADE
K830434 · Concept, Inc. · Apr 1983