510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232405Substantially Equivalent

Endofix Exo

AKTORmed GmbH, Neutraubling, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232405 is the FDA 510(k) clearance record for ENDOFIX EXO, a class II device, cleared for Aktormed GmbH on under FDA product code OCV (Endoscope Holder). FDA's definition for product code OCV reads: "To hold endoscope in a desired position during procedures". FDA records list 5 510(k) clearances for Aktormed GmbH, from to . As of , FDA records show no recalls naming K232405.

Clearance record

Decision date
Received
(259 days to decision)
Product code
OCV Endoscope Holder
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Aktormed GmbH Neugablonzer Strasse 13, Neutraubling, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCV

Trailing 12 months

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

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