Cleared Traditional

K934583 - BURRS

K934583 is an FDA 510(k) clearance for BURRS, manufactured by American Medical Specialties, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GFF cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K934583 · American Medical Specialties, Inc. · General & Plastic Surgery device
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Jan 1994
Decision
125d
Days
Class 1
Risk

K934583 is an FDA 510(k) clearance for the BURRS. Classified as Bur, Surgical, General & Plastic Surgery (product code GFF), Class I - General Controls.

Submitted by American Medical Specialties, Inc. (Roswell, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 125 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 American Medical Specialties, Inc. devices

FDA 510(k) Submission Details - K934583

510(k) Number K934583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1993
Decision Date January 26, 1994
Days to Decision 125 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
10d slower than avg
Panel avg: 115d · This submission: 125d
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 9
Devices cleared under the same product code (GFF) and FDA review panel - the closest regulatory comparables to K934583.
ANSPACH SHIELDED ATTACHMENT
K974025 · The Anspach Effort, Inc. · Jul 1998
SURGICAL BUR
K950449 · Transidyne General Corp. · Mar 1995
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
SURGICAL BURS
K880859 · New England Surgical Instrument Corp. · Mar 1988
MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR
K862852 · Micro-Aire Surgical Instruments, Inc. · Aug 1986