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Swiss Lithoclast Multipurpose Probe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K992251

by Electro Medical Systems SA

Identifiers

510(k) Number
K992251 FDA 510(k)
FDA Product Code
FFK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4480 FDA 510(k)
Regulation Number
876.4480 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Swiss Lithoclast Multipurpose Probe by Electro Medical Systems SA — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K992251 24 fields · synced Jun 18, 2026