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1.9 French Lithotriptor Electrode, Modification

FDA 510(k)

Class II (US FDA 510(k))

510(k) K913955

by Northgate Technologies Inc.

Identifiers

510(k) Number
K913955 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)

This device is an electro-hydraulic lithotriptor electrode, designed for the fragmentation of urinary or biliary calculi (stones) via high-energy shockwaves generated by electrical discharge. It operates within the urinary or biliary tract to break stones into smaller particles for easier passage or subsequent removal.

The 1.9 French Lithotriptor Electrode is supplied as a reusable medical device, intended for use in gastroenterology and urology procedures. It adheres to FDA 510(k) clearance (K913955) under regulation 876.4480, classified as a Class II device with special controls. The electrode is not MRI-safe and must be handled in accordance with sterile or aseptic techniques as dictated by clinical protocols.

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: K913955 FDA 510 (k) - 1.9 FRENCH LITHOTRIPTER ELECTRODE, 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION… - FDA.report, 1.9 French Lithotripter Electrode, Modification

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Northgate Technologies Inc.
FDA Applicant
Northgate Technologies, Inc.

Sources (1)

  • FDA 510(k) K913955 24 fields · synced Sep 19, 2026