Deflecting Ureteral Access Sheath
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K030642 FDA 510(k)
- FDA Product Code
- FED 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 Deflecting Ureteral Access Sheath is an endoscopic access overtube used in gastroenterology and urology procedures. It consists of two components: a sheath and a dilator, with the sheath featuring an elongated body attached to a lever and handle assembly that enables tip deflection upon activation.
The device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user. It is indicated for facilitating the passage of endoscopes and other instruments during endoscopic urology procedures, as supported by its 510(k) clearance K030642 under regulation 876.1500, with product code FED and classification as a Class II device.
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: DEFLECTING URETERAL ACCESS SHEATH 510(k) K030642 - FDA.report, DEFLECTING URETERAL ACCESS SHEATH (K030642) — FDA 510 (k) - Innolitics, PDF MAY 2 3 2003 - accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030642 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corp.
Sources (1)
- FDA 510(k) K030642 24 fields · synced Sep 24, 2026