CLEARCUT S SAFETY KNIFE— 510(k) K110166
Substantially EquivalentAlcon Research, Ltd.
FDA 510(k) clearance K110166 for CLEARCUT S SAFETY KNIFE, Substantially Equivalent on 2011-05-20. Applicant: Alcon Research, Ltd.. Device class: 1.
Clearance details
- Applicant
- Alcon Research, Ltd.
- Product code
- Code HNN
- Device class
- Class 1
- Regulation
- 21 CFR 886.4350
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Fort Worth, TX, US
Recent devices under product code HNN
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- K170520 — HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
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- K121031 — WAVELIGHT FS200 PATIENT INTERFACE 1505
- K112977 — MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
Adverse events under product code HNN
product code HNN- Injury
- 183
- Malfunction
- 4,106
- Total
- 4,289
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 K110166
K-number listed on FDA's recall record- Z-1922-2024 — 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
- Z-1923-2024 — ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
- Z-1924-2024 — ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
- Z-1925-2024 — ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110166.
Data sourced from openFDA. This site is unofficial and independent of the FDA.