Cleared Traditional

K950449 - SURGICAL BUR

K950449 is the FDA 510(k) clearance for SURGICAL BUR by Transidyne General Corp.. It is a Class 1 General & Plastic Surgery device (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.

View all Transidyne General Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (GFF) and FDA review panel - the closest regulatory comparables to K950449.
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