CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM— 510(k) K081459

Name: FDA 510(k) clearance K081459
Creator: U.S. Food and Drug Administration
Published: 2008-08-13

Substantially Equivalent

Integra Radionics, Inc.

FDA 510(k) clearance K081459 for CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM, Substantially Equivalent on 2008-08-13. Applicant: Integra Radionics, Inc.. Device class: Unclassified.

Clearance details

Applicant: Integra Radionics, Inc.
Product code: Code LFL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2008-05-23
Decision date: 2008-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFL

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K261448 — neXus Ultrasonic Surgical Aspirator System2026-07-30
K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System2025-10-08
K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10) +4 more2025-06-18
K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000)2025-03-24
K241700 — Tenex 2nd Generation System2024-11-18

More clearances from Integra Radionics, Inc.

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K102258 — CUSA NXT EXTENDED LENGTH TIP2011-06-10
K100096 — LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART2010-04-22
K100417 — XKNIFE 52010-04-08
K090864 — CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM2009-05-08
K083414 — RADIONICS XKNIFE HDRT SYSTEM2009-03-02

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K081459

K-number listed on FDA's recall record

Z-0491-2015 — Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing lumen transmits aspirated fluid and tissue back to the system console. The aspirator is intended to be used to facilitate the removal of cellular and other unwanted soft tissue. The system provides selective tissue disintegration with simultaneous irrigation and aspiration. The system has been designed for use by surgeons in the areas of neurosurgery and gastroenterology including laparoscopic procedures. Its use in other procedures is regarded as experimental and is thus subjecto to appropriate local regulatory approvalClass II·Terminated·Integra LifeSciences Corp.·20140929

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081459.

Data sourced from openFDA. This site is unofficial and independent of the FDA.