SURGICAL ILLUMINATOR (SIL)— 510(k) K770568

Name: FDA 510(k) clearance K770568
Creator: U.S. Food and Drug Administration
Published: 1977-04-14

Substantially Equivalent

Fiber Optics Engineering, Inc.

FDA 510(k) clearance K770568 for SURGICAL ILLUMINATOR (SIL), Substantially Equivalent on 1977-04-14. Applicant: Fiber Optics Engineering, Inc.. Device class: 2.

Clearance details

Applicant: Fiber Optics Engineering, Inc.
Product code: Code FTD
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1977-03-25
Decision date: 1977-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K770567 — LIGHT, EXAMINATION, MEDICAL (MEL)1977-04-14

Adverse events under product code FTD

product code FTD

Malfunction: 767
Total: 767

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.