CUSA Clarity Ultrasonic Surgical Aspirator System

Instrument, Ultrasonic Surgical

Integra LifeSciences Corporation

The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Cusa Clarity Ultrasonic Surgical Aspirator System.

Pre-market Notification Details

A PHP Error was encountered

Severity: Warning

Message: strpos(): Empty needle

Filename: fda.report/pmn_item.php

Line Number: 100

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 100
Function: strpos

• Device ID: K190180
• 510k Number: K190180
• Device Name: CUSA Clarity Ultrasonic Surgical Aspirator System
• Classification: Instrument, Ultrasonic Surgical
• Applicant: Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536
• Contact: Alexandra Wells
• Correspondent: Alexandra Wells; Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536
• Product Code: LFL
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-02-01
• Decision Date: 2019-04-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10381780466383	K190180	000
30381780466219	K190180	000