DeviceClearance

AXCEL SURGICAL LIGHT— 510(k) K030906

Substantially Equivalent

Alm

FDA 510(k) clearance K030906 for AXCEL SURGICAL LIGHT, Substantially Equivalent on 2003-04-23. Applicant: Alm. Device class: 2.

Clearance details

Applicant
Alm
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 K030906

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 K030906.

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