Cleared Traditional

K950449 - SURGICAL BUR

K950449 is an FDA 510(k) clearance for SURGICAL BUR, manufactured by Transidyne General Corp.. The device is a Class 1 General & Plastic Surgery device with product code GFF cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K950449 · Transidyne General Corp. · General & Plastic Surgery device
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Mar 1995
Decision
26d
Days
Class 1
Risk

K950449 is an FDA 510(k) clearance for the SURGICAL BUR. Classified as Bur, Surgical, General & Plastic Surgery (product code GFF), Class I - General Controls.

Submitted by Transidyne General Corp. (Spartanburg, US). The FDA issued a Cleared decision on March 1, 1995 after a review of 26 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K950449

510(k) Number K950449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1995
Decision Date March 01, 1995
Days to Decision 26 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

GFF Device Classification - Class 1, General Controls

Product Code GFF Bur, Surgical, General & Plastic Surgery
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 - GFF Bur, Surgical, General & Plastic Surgery

All 15
Devices cleared under the same product code (GFF) and FDA review panel - the closest regulatory comparables to K950449.
ANSPACH SHIELDED ATTACHMENT
K974025 · The Anspach Effort, Inc. · Jul 1998
SURGICAL BUR
K943758 · Komet Medical · Aug 1994
BURRS
K934583 · American Medical Specialties, Inc. · Jan 1994
MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS
K894438 · Micro-Aire Surgical Instruments, Inc. · Aug 1989
DANEK IRRIGATING BURR (DIB) SET
K890090 · Danek Medical, Inc. · Jan 1989
KOMET SURGICAL BUR
K883255 · Komet Medical, Div. of Brasseler USA I, L.P. · Sep 1988
K950449 · SURGICAL BUR
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