510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K941715Substantially Equivalent

Ultathin Flexible Endoscope

Technology Marketing Group, Maywood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941715 is the FDA 510(k) clearance record for ULTATHIN FLEXIBLE ENDOSCOPE, a class II device, cleared for Technology Marketing Group on under FDA product code LYK (Angioscope). FDA records list 3 510(k) clearances for Technology Marketing Group, from to . As of , FDA records show no recalls naming K941715.

Clearance record

Decision date
Received
(180 days to decision)
Product code
LYK Angioscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Technology Marketing Group 525 Palmer Ave., Maywood NJ
510(k) summary
Statement
Third party review
No

Clearances, product code LYK

Trailing 12 months
1 clearance under product code LYK in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LYK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260