CUSA Clarity Ultrasonic Surgical Aspirator System— 510(k) K182809
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K182809 for CUSA Clarity Ultrasonic Surgical Aspirator System, Substantially Equivalent on 2018-12-07. Applicant: Integra LifeSciences Corporation. Device class: Unclassified.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code LFL
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Planisboro, NJ, US
Recent devices under product code LFL
view allMore clearances from Integra LifeSciences Corporation
view all- K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
- K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K221835 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K221763 — CUSA Clarity Ultrasonic Surgical Aspirator System
Adverse events under product code LFL
product code LFL- Death
- 29
- Injury
- 1,046
- Malfunction
- 21,642
- Total
- 22,717
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 K182809
K-number listed on FDA's recall record- Z-0613-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0614-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0615-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0616-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0617-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0618-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0619-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0620-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0621-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0622-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0623-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0624-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0625-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0626-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0627-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0628-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0629-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0630-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0631-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Z-0632-2020 — C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182809.
Data sourced from openFDA. This site is unofficial and independent of the FDA.