CUSA Clarity Ultrasonic Surgical Aspirator System— 510(k) K161882
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K161882 for CUSA Clarity Ultrasonic Surgical Aspirator System, Substantially Equivalent on 2016-10-14. 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 K161882
K-number listed on FDA's recall record- Z-1828-2026 — CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
- Z-0694-2018 — Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses are cleared for use in the US only: Gastrointestinal and Affiliated Organ Surgery including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery including removal of benign or malignant tumors or other unwanted soft tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161882.
Data sourced from openFDA. This site is unofficial and independent of the FDA.