510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K893440Substantially Equivalent

Flex Sigmoidoscope Light Source Model #45150

Welch Allyn Inc, Skaneateles Falls NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893440 is the FDA 510(k) clearance record for FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150, a class II device, cleared for Welch Allyn, Inc. on under FDA product code FFS (Image, Illumination, Fiberoptic, For Endoscope). FDA records list 112 510(k) clearances for Welch Allyn, Inc., from to . As of , FDA records show no recalls naming K893440.

Clearance record

Decision date
Received
(86 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
Welch Allyn, Inc. 4341 State St. Rd., Skaneateles Falls NY
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FFS, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260