1.9 FRENCH LITHOTRIPTER ELECTRODE— 510(k) K903337

Name: FDA 510(k) clearance K903337
Creator: U.S. Food and Drug Administration
Published: 1990-11-16

Substantially Equivalent

Northgate Research, Inc.

FDA 510(k) clearance K903337 for 1.9 FRENCH LITHOTRIPTER ELECTRODE, Substantially Equivalent on 1990-11-16. Applicant: Northgate Research, Inc.. Device class: 2.

Clearance details

Applicant: Northgate Research, Inc.
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 1990-07-25
Decision date: 1990-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FFK

view all

K242888 — Electrohydraulic Lithotriptor (TCS-B3-II)2025-03-21
K243032 — EHL Probe (3 models)2025-03-21
K230488 — EL27-Compact; Sterile EHL-Probes2023-08-31
K202813 — URO-TOUCH 9 French Probe2021-06-14
K191124 — Swiss LithoClast Trilogy2019-05-29

More clearances from Northgate Research, Inc.

view all

K894704 — 2.5 FRENCH LITHOTRIPTOR ELECTRODE1989-10-18
K891252 — UROLOGICAL LOOP RETRIEVERS1989-03-22
K891253 — UROLOGICAL GRASPING FORCEPS1989-03-22
K891254 — UROLOGICAL STONE BASKET1989-03-22
K864904 — 3F ELECTRODE1987-02-10

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