DeviceClearance

POWERLED SURGICAL LIGHT SYSTEM— 510(k) K070442

Substantially Equivalent

Maquet S.A.

FDA 510(k) clearance K070442 for POWERLED SURGICAL LIGHT SYSTEM, Substantially Equivalent on 2007-03-16. Applicant: Maquet S.A.. Device class: 2.

Clearance details

Applicant
Maquet S.A.
Product code
Code FSY
Device class
Class 2
Regulation
21 CFR 878.4580
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Rochester, NY, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FSY

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Adverse events under product code FSY

product code FSY
Malfunction
2,759
Other
1
Total
2,760

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K070442

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070442.

Data sourced from openFDA. This site is unofficial and independent of the FDA.