Identifiers
- 510(k) Number
- K242586 FDA 510(k)
- FDA Product Code
- OCX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ArgoCap 200.52 is an endoscopic irrigation and suction system accessory designed for use in the gastrointestinal tract. It serves as an endoscopic attachment cap to facilitate safe and precise treatment procedures.
This device is manufactured by Ovesco Endoscopy AG and has received FDA 510(k) clearance. It is classified as a Class II medical device under regulation 21 CFR 876.1500.
Frequently asked questions
What is the primary function of the ArgoCap 200.52?
The ArgoCap 200.52 is an endoscopic irrigation and suction system accessory. It is designed to be used as an attachment cap during procedures in the gastrointestinal tract to assist in providing safe and precise treatment.
What is the regulatory status of this device?
The ArgoCap 200.52 has received FDA 510(k) clearance. It is classified as a Class II medical device under regulation 21 CFR 876.1500.
Who is the manufacturer of the ArgoCap 200.52?
The device is manufactured by Ovesco Endoscopy AG, which is based in Tuebingen, Germany.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ovesco Endoscopy AG - ArgoCap®, PDF Ovesco Endoscopy AG ℅ Maria Kiel - accessdata.fda.gov, ArgoCap (200.52) (K242586) — FDA 510 (k) | Innolitics, ArgoCap (K242586) | Medical Device Navigator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242586 | Class II | Active |
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Manufacturer
- Manufacturer
- Ovesco Endoscopy Ag
Sources (1)
- FDA 510(k) K242586 24 fields · synced Sep 27, 2026