510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161222Substantially Equivalent

PENTAX MEDICAL ED-3490TK, Video Duodenoscope

PENTAX of America, Inc., Montvale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161222 is the FDA 510(k) clearance record for PENTAX MEDICAL ED-3490TK, Video Duodenoscope, a class II device, cleared for Pentax Medical on under FDA product code FDT (Duodenoscope And Accessories, Flexible/Rigid). FDA's definition for product code FDT reads: "To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82...". FDA records list 72 510(k) clearances for PENTAX of America, Inc., from to . As of , FDA records show one recall naming K161222.

Clearance record

Decision date
Received
(649 days to decision)
Product code
FDT Duodenoscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pentax Medical 3 Paragon Dr.,, Montvale NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FDT

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