Cleared Traditional

ArgoCap (200.52)

K242586 · Ovesco Endoscopy AG · Gastroenterology & Urology

May 2025

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K242586 is an FDA 510(k) clearance for the ArgoCap (200.52), a Endoscopic Irrigation/suction System (Class II — Special Controls, product code OCX), submitted by Ovesco Endoscopy AG (Tuebingen, DE). The FDA issued a Cleared decision on May 22, 2025, 265 days after receiving the submission on August 30, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K242586 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2024
Decision Date	May 22, 2025
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	OCX — Endoscopic Irrigation/suction System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.