510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K014060Substantially Equivalent

Microaire 1000E System

MicroAire Surgical Instruments, LLC, Charlottesville VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014060 is the FDA 510(k) clearance record for MICROAIRE 1000E SYSTEM, a class II device, cleared for Microaire Surgical Instruments, Inc. on under FDA product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)). FDA records list 16 510(k) clearances for Microaire Surgical Instruments, Inc., from to . As of , FDA records show no recalls naming K014060.

Clearance record

Decision date
Received
(85 days to decision)
Product code
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Regulation
21 CFR 882.4310
Device class
Class II
Review panel
Neurology
Applicant
Microaire Surgical Instruments, Inc. 1641 Edlich Dr., Charlottesville VA
510(k) summary
Summary
Third party review
No

Clearances, product code HBE

Trailing 12 months
2 clearances under product code HBE in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HBE, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260