Cleared Traditional

K880706 - SURGICAL BURS

K880706 is an FDA 510(k) clearance for SURGICAL BURS, manufactured by Nuell Air Equipment & Hospital Supplies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GFF cleared through the Traditional 510(k) pathway after a 4-day FDA review.

K880706 · Nuell Air Equipment & Hospital Supplies, Inc. · General & Plastic Surgery device
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Feb 1988
Decision
4d
Days
Class 1
Risk

K880706 is an FDA 510(k) clearance for the SURGICAL BURS. Classified as Bur, Surgical, General & Plastic Surgery (product code GFF), Class I - General Controls.

Submitted by Nuell Air Equipment & Hospital Supplies, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 26, 1988 after a review of 4 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 Nuell Air Equipment & Hospital Supplies, Inc. devices

FDA 510(k) Submission Details - K880706

510(k) Number K880706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1988
Decision Date February 26, 1988
Days to Decision 4 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 115d · This submission: 4d
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 K880706.
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
MICRO-AIRE GENERIC BURS & DRILLS
K850497 · Micro-Aire Surgical Instruments, Inc. · Mar 1985
HOLE CHAMFERING DEVICE
K841298 · Techmedica, Inc. · Apr 1984