Cleared Traditional

K872491 - 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS

K872491 is an FDA 510(k) clearance for 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS, manufactured by Micro-Aire Surgical Instruments, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEG cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K872491 · Micro-Aire Surgical Instruments, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1987
Decision
23d
Days
Class 1
Risk

K872491 is an FDA 510(k) clearance for the 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS. Classified as Elevator, Surgical, General & Plastic Surgery (product code GEG), Class I - General Controls.

Submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on July 16, 1987 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Micro-Aire Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K872491

510(k) Number K872491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1987
Decision Date July 16, 1987
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

GEG Device Classification - Class 1, General Controls

Product Code GEG Elevator, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GEG Elevator, Surgical, General & Plastic Surgery

All 9
Devices cleared under the same product code (GEG) and FDA review panel - the closest regulatory comparables to K872491.
SEPTUM ELEVATOR
K890365 · Kinetic Medical Products · Feb 1989
LIGATURE NEEDLES
K890230 · Kinetic Medical Products · Jan 1989
SURGICAL ELEVATOR
K890253 · Kinetic Medical Products · Jan 1989
ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS
K870781 · Buckman Co., Inc. · Mar 1987
FEMUR WRENCH
K870126 · Orthopedic Systems, Inc. · Feb 1987
H.R. JAKOBI SURG. INSTRUMENTS 40/41
K834176 · Imm Enterprises , Ltd. · Jan 1984