510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K940270Substantially Equivalent

Lci-100 and Lci-200 Welch Allyn Illumination and Imaging System

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

K940270 is the FDA 510(k) clearance record for LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM, a class II device, cleared for Welch Allyn, Inc. on under FDA product code GCT (Light Source, Endoscope, Xenon Arc). FDA records list 112 510(k) clearances for Welch Allyn, Inc., from to . As of , FDA records show no recalls naming K940270.

Clearance record

Decision date
Received
(89 days to decision)
Product code
GCT Light Source, Endoscope, Xenon Arc
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Welch Allyn, Inc. 4619 Jordan Rd., Skaneateles Falls NY
510(k) summary
Summary
Third party review
No

Clearances, product code GCT

Trailing 12 months

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

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