510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894592Substantially Equivalent

Lamano Directors

Marlo Surgical Technology, Willoughby OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894592 is the FDA 510(k) clearance record for LAMANO DIRECTORS, a class II device, cleared for Marlo Surgical Technology on under FDA product code GCM (Endoscope, Rigid). FDA records list 28 510(k) clearances for Marlo Surgical Technology, from to . As of , FDA records show no recalls naming K894592.

Clearance record

Decision date
Received
(46 days to decision)
Product code
GCM Endoscope, Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Marlo Surgical Technology 1810 Joseph Lloyd Pkwy., Willoughby OH
Third party review
No

Clearances, product code GCM

Trailing 12 months

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

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