SKYTRON UNIVERSE SERIES SURGICAL LIGHTS— 510(k) K900211

Name: FDA 510(k) clearance K900211
Creator: U.S. Food and Drug Administration
Published: 1990-03-19

Substantially Equivalent

Skytron, Div. the Kmw Group, Inc.

FDA 510(k) clearance K900211 for SKYTRON UNIVERSE SERIES SURGICAL LIGHTS, Substantially Equivalent on 1990-03-19. Applicant: Skytron, Div. the Kmw Group, Inc.. Device class: 2.

Clearance details

Applicant: Skytron, Div. the Kmw Group, Inc.
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1990-01-17
Decision date: 1990-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSY

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K142984 — Leo Minor2014-10-29
K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT2014-09-30
K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT2014-08-07
K132551 — ZF 7202014-06-30
K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES2014-06-09

More clearances from Skytron, Div. the Kmw Group, Inc.

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K071698 — AURORA LED SERIES SURGICAL LIGHTS2007-07-06
K021585 — STELLAR SERIES SURGICAL LIGHTS WITH HERMES2002-11-13
K002463 — STELLAR2000-11-08
K992090 — MILLENNIUM GOLD1999-09-08
K950192 — SKYTRON SKYBOOM SERIES1995-04-03

Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

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.