1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION— 510(k) K914514

Name: FDA 510(k) clearance K914514
Creator: U.S. Food and Drug Administration
Published: 1992-01-06

Substantially Equivalent

Northgate Technologies, Inc.

FDA 510(k) clearance K914514 for 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION, Substantially Equivalent on 1992-01-06. Applicant: Northgate Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Northgate Technologies, Inc.
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-09
Decision date: 1992-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K914514

K-number listed on FDA's recall record

Z-0073-2018 — Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.Class II·Terminated·Northgate Technologies, Inc.·20170524

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K914514.

Data sourced from openFDA. This site is unofficial and independent of the FDA.