9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION— 510(k) K914516

Name: FDA 510(k) clearance K914516
Creator: U.S. Food and Drug Administration
Published: 1992-01-07

Substantially Equivalent

Northgate Technologies, Inc.

FDA 510(k) clearance K914516 for 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION, Substantially Equivalent on 1992-01-07. 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: 1992-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K914516

K-number listed on FDA's recall record

Z-1885-2020 — ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.Class II·Terminated·Northgate Technologies, Inc.·20200310

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K914516.

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