50 W METAL HALIDE ILLUMINATOR, VES 0501.— 510(k) K992447

Name: FDA 510(k) clearance K992447
Creator: U.S. Food and Drug Administration
Published: 1999-10-20

Substantially Equivalent

Angiolaz, Inc.

FDA 510(k) clearance K992447 for 50 W METAL HALIDE ILLUMINATOR, VES 0501., Substantially Equivalent on 1999-10-20. Applicant: Angiolaz, Inc.. Device class: 2.

Clearance details

Applicant: Angiolaz, Inc.
Product code: Code FCW
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1999-07-22
Decision date: 1999-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellows Falls, VT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FCW

view all

K131226 — NOVAPROBE LED LIGHT SOURCE2014-07-24
K123956 — POWER LED 1752013-01-25
K123359 — OVS1 VIDEO SYSTEM2012-12-19
K121724 — ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.22012-09-20
K093792 — LED LIGHT SOURCE2010-03-18

More clearances from Angiolaz, Inc.

view all

K994362 — HEADLAMP HL2000.2000-05-11
K982397 — VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM1998-09-10
K982409 — VES 1501-M1998-08-21
K981819 — ANGIOLAZ VES-1CAM1998-08-04
K981821 — VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR1998-07-29

Adverse events under product code FCW

product code FCW

Malfunction: 912
Other: 1
Total: 913

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.