510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915670Substantially Equivalent

Microaire Model 2600

Microaire, Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915670 is the FDA 510(k) clearance record for MICROAIRE MODEL 2600, a class I device, cleared for Microaire on under FDA product code GEF (Applier, Staple, Surgical,). FDA records list 3 510(k) clearances for Microaire, from to . As of , FDA records show no recalls naming K915670.

Clearance record

Decision date
Received
(90 days to decision)
Product code
GEF Applier, Staple, Surgical,
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Microaire 24971 Ave. Stanford W., Valencia CA
510(k) summary
Statement
Third party review
No

Clearances, product code GEF

Trailing 12 months

FDA records hold no clearances under product code GEF in the trailing twelve months.

FDA records show no clearances under product code GEF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GEF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260