DeviceClearance

27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA— 510(k) K110951

Substantially Equivalent

Alcon Research, Ltd.

FDA 510(k) clearance K110951 for 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA, Substantially Equivalent on 2011-10-17. Applicant: Alcon Research, Ltd.. Device class: 2.

Clearance details

Applicant
Alcon Research, Ltd.
Product code
Code HQB
Device class
Class 2
Regulation
21 CFR 886.4690
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Alcon Research, Ltd.

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Adverse events under product code HQB

product code HQB
Other
2
Total
2

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 K110951

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 K110951.

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