9100 DAYSTAR AND 9110 ORBITER PACKAGE— 510(k) K781887

Substantially Equivalent

Castle Co.

FDA 510(k) clearance K781887 for 9100 DAYSTAR AND 9110 ORBITER PACKAGE, Substantially Equivalent on 1978-12-12. Applicant: Castle Co..

Clearance details

Applicant: Castle Co.
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 1978-11-07
Decision date: 1978-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.