Atrion Medical QL Inflation Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K032840 FDA 510(k)
- FDA Product Code
- KOE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5520 FDA 510(k)
- Regulation Number
- 876.5520 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Atrion Medical QL Inflation Device is a Dilator, Urethral, designed for controlled inflation and fluid delivery in urological and gastroenterological procedures. It facilitates precise balloon catheterization and stent deployment, ensuring accurate pressure and volume control during interventions.
This device is supplied as a single-use, non-sterile instrument, intended for use in clinical settings where sterile conditions can be achieved. It is classified under FDA regulation 876.5520 and holds a FDA 510K clearance (K032840). Multiple sizes and configurations are available, as referenced by the associated FEI numbers, to accommodate various procedural requirements.
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: Atrion QL® Inflation Devices - Nordson MEDICAL, Atrion Medical Devices, PDF Atrion Medical Products QL® Inflation Devices Brochure (Web Version ..., PDF INFLATION DEVICES - Atrion Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032840 | Class II | Active |
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Manufacturer
- Manufacturer
- Atrion Medical Products, Inc.
Sources (1)
- FDA 510(k) K032840 24 fields · synced Oct 6, 2026