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
K905097Substantially Equivalent

Micro-Aire Model Number: Mk-426

Micro Surgical Instruments Corp., Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905097 is the FDA 510(k) clearance record for MICRO-AIRE MODEL NUMBER: MK-426, a class II device, cleared for Micro Surgical Instruments Corp. on under FDA product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)). FDA records list 15 510(k) clearances for Micro Surgical Instruments Corp., from to . As of , FDA records show no recalls naming K905097.

Clearance record

Decision date
Received
(38 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
Micro Surgical Instruments Corp. 24971 Ave. Stanford W., Valencia CA
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