MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE— 510(k) K905124

Name: FDA 510(k) clearance K905124
Creator: U.S. Food and Drug Administration
Published: 1991-01-25

Substantially Equivalent

Red Wing Imaging, Inc.

FDA 510(k) clearance K905124 for MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE, Substantially Equivalent on 1991-01-25. Applicant: Red Wing Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Red Wing Imaging, Inc.
Product code: Code GCT
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1990-11-14
Decision date: 1991-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCT

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K093125 — ALPHAXENON LIGHT 180 W AND 300 W2010-01-27
K082925 — XENON-100 SCB LIGHT SOURCE, MODEL 201326202008-12-18
K070376 — CONMED LINVATEC 300W XENON LIGHT SOURCE2007-08-20
K040949 — VIADUCT MINISCOPE AND ACCESSORIES2004-05-07
K022490 — KSEA MEDI PACK2003-09-29

Adverse events under product code GCT

product code GCT

Malfunction: 1,393
Other: 2
Total: 1,395

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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