CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM— 510(k) K141674
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K141674 for CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM, Substantially Equivalent on 2014-11-06. 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
- Plainsboro, 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 K141674
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141674.
Data sourced from openFDA. This site is unofficial and independent of the FDA.