Cleared Traditional

CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM

K981262 · Valleylab, Inc. · General & Plastic Surgery
Jul 1998
Decision
90d
Days
—
Risk

About This 510(k) Submission

K981262 is an FDA 510(k) clearance for the CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM, a Instrument, Ultrasonic Surgical, submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on July 6, 1998, 90 days after receiving the submission on April 7, 1998. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K981262 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1998
Decision Date July 06, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class —

Similar Devices — LFL Instrument, Ultrasonic Surgical

All 156
CUSA? Clarity Ultrasonic Surgical Aspirator System
K251162 · Integra LifeSciences Corporation · Oct 2025
SanAgile? Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile? Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile? Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile? Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile? Ultrasonic Surgery Advanced Dissector (SASD45)
K242894 · Shanghai Saints Sages Surgical Co., Ltd. · Jun 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930 · Stryker Instruments · Mar 2025
Tenex 2nd Generation System
K241700 · Trice Medical, Inc. · Nov 2024
CUSA? Clarity Ultrasonic Surgical Aspirator System
K240493 · Integra LifeSciences Corporation · Jul 2024
Ultrasonic Surgical System
K233036 · Hunan Handlike Minimally Invasive Surgery Co., Ltd. · Jun 2024