Cleared Traditional

K934583 - BURRS

K934583 is the FDA 510(k) clearance for BURRS by American Medical Specialties, Inc.. It is a Class 1 General & Plastic Surgery device (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 K934583.
ANSPACH SHIELDED ATTACHMENT
K974025 · The Anspach Effort, Inc. · Jul 1998
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
MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR
K862852 · Micro-Aire Surgical Instruments, Inc. · Aug 1986
MICRO-AIRE GENERIC BURS & DRILLS
K850497 · Micro-Aire Surgical Instruments, Inc. · Mar 1985
MICRO-AIRE REPLACEMENT DRILL BURS
K820281 · Micro-Aire Surgical Instruments, Inc. · Feb 1982