510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890448Substantially Equivalent

Light Source, Endoscop, Xenon Arc

Mira, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890448 is the FDA 510(k) clearance record for LIGHT SOURCE, ENDOSCOP, XENON ARC, a class II device, cleared for Mira, Inc. on under FDA product code FFS (Image, Illumination, Fiberoptic, For Endoscope). FDA records list 19 510(k) clearances for Mira, Inc., from to . As of , FDA records show no recalls naming K890448.

Clearance record

Decision date
Received
(101 days to decision)
Product code
FFS Image, Illumination, Fiberoptic, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mira, Inc. 87 Rumford Ave., Waltham MA
Third party review
No

Clearances, product code FFS

Trailing 12 months

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

FDA records show no clearances under product code FFS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FFS, 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