510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840837Substantially Equivalent

Tbi Trainer

Manico, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840837 is the FDA 510(k) clearance record for TBI TRAINER, a class I device, cleared for Manico on under FDA product code FEJ (Attachment, Binocular, For Endoscope). FDA records list one 510(k) clearance for Manico. As of , FDA records show no recalls naming K840837.

Clearance record

Decision date
Received
(395 days to decision)
Product code
FEJ Attachment, Binocular, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Manico 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FEJ

Trailing 12 months

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

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