DAYSTAR SELECTRA & SELECTRA/ORBITER— 510(k) K780666

Name: FDA 510(k) clearance K780666
Creator: U.S. Food and Drug Administration
Published: 1978-04-27

Substantially Equivalent

Castle Co.

FDA 510(k) clearance K780666 for DAYSTAR SELECTRA & SELECTRA/ORBITER, Substantially Equivalent on 1978-04-27. Applicant: Castle Co.. Device class: 2.

Clearance details

Applicant: Castle Co.
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1978-03-10
Decision date: 1978-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSY

view all

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 Castle Co.

view all

K870975 — MODIFIED CASTLE POWERCLAVE1987-04-17
K860263 — CASTLE 7538 FLOOR LOADING WASHER1986-03-05
K844089 — CASTLE 7515 UTENSIL/GLASSWARE WASHER1985-01-14
K834048 — BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO1984-04-04
K833074 — CASTLE TEC-TEST S.M.A.R.T. PACK1983-11-07

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.