FDA 510(k) clearance · back to tracker

CUSA® Clarity Ultrasonic Surgical Aspirator System

Integra LifeSciences Corporation cleared K251162 on 2025-10-08, decision: substantially equivalent

K-number

K251162

Sponsor

Integra LifeSciences Corporation

Device

CUSA® Clarity Ultrasonic Surgical Aspirator System

Class

Class U

Decision

Substantially Equivalent

Decision date

2025-10-08

Product code

LFL

Advisory committee

Unknown

Medical specialty

Unknown

Regulation number

Official FDA record

Open K251162on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.