510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160797Substantially Equivalent

FMX314 Surgical Platform

Fortimedix Surgical B.V., Nuth, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160797 is the FDA 510(k) clearance record for FMX314 Surgical Platform, a class II device, cleared for Fortimedix Surgical B.V. on under FDA product code OTJ (Laparoscopic Single Port Access Device). FDA's definition for product code OTJ reads: "A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery". FDA records list one 510(k) clearance for Fortimedix Surgical B.V. As of , FDA records show no recalls naming K160797.

Clearance record

Decision date
Received
(156 days to decision)
Product code
OTJ Laparoscopic Single Port Access Device
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Fortimedix Surgical B.V. Daelderweg 20, Nuth, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OTJ

Trailing 12 months

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

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