510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982462Substantially Equivalent

Fiber Optic Endoillumination Probe

Microvision, Inc., Seabrook NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982462 is the FDA 510(k) clearance record for FIBER OPTIC ENDOILLUMINATION PROBE, a class II device, cleared for Microvision, Inc. on under FDA product code FFS (Image, Illumination, Fiberoptic, For Endoscope). FDA records list 3 510(k) clearances for Microvision, Inc., from to . As of , FDA records show no recalls naming K982462.

Clearance record

Decision date
Received
(61 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
Microvision, Inc. 34 Folly Mill Rd., Seabrook NH
510(k) summary
Summary
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