Cusa NXT Extended Length Tip
FDA 510(k) K102258 · Integra Radionics, Inc.
510(k) numberK102258
Submission
- Device name
- Cusa NXT Extended Length Tip
- Applicant
- Integra Radionics, Inc.
Burlington, MA, US - Received
- August 10, 2010
- Decision date
- June 10, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFL – Instrument, Ultrasonic Surgical
- Device class
- Unclassified
Other 510(k)s with product code LFL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261448 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | Misonix, LLC | 07/30/2026SE |
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 10/08/2025SE |
| K242894 | SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic…LFL · Traditional | Shanghai Saints Sages Surgical Co., Ltd. | 06/18/2025SE |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFL · Traditional | Stryker Instruments | 03/24/2025SE |
| K241700 | Tenex 2nd Generation SystemLFL · Traditional | Trice Medical, Inc. | 11/18/2024SE |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 07/11/2024SE |
| K233036 | Ultrasonic Surgical SystemLFL · Traditional | Hunan Handlike Minimally Invasive Surgery Co.… | 06/18/2024SE |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 07/11/2023SE |
| K231117 | neXus Ultrasonic Surgical Aspirator SystemLFL · Special | Misonix, LLC, A Bioventus Company | 06/23/2023SE |
| K221790 | HARMONIC 700 ShearsLFL · Traditional | Ethicon Endo-Surgery, LLC | 02/28/2023SE |
More from Ethicon Endo-Surgery, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K100096 | Linac Collimator Assembly Housing (Lcah) Model LcahartIYE · Traditional | 04/22/2010SE |
| K100417 | Xknife 5MUJ · Traditional | 04/08/2010SE |
| K090864 | Cusa Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical Aspirator SystemLFL · Traditional | 05/08/2009SE |
| K083414 | Radionics Xknife HDRT SystemMUJ · Traditional | 03/02/2009SE |
| K081459 | Cusa Selector NXT Ultrasonic Tissue Ablation SystemLFL · Traditional | 08/13/2008SE |
| K072454 | Integra Radionics Interfix Patient AdaptersIYE · Traditional | 10/16/2007SE |
| K071669 | Integra Selector Ultrasonic Surgical Aspirator System with Bone TipLFL · Traditional | 08/17/2007SE |
| K063230 | Integra Radionics Imagefusion 3MUJ · Special | 12/21/2006SE |
| K061893 | Integra Radionics Xknife RT 4MUJ · Special | 07/25/2006SE |
Questions and answers
When was Cusa NXT Extended Length Tip cleared by the FDA?
Cusa NXT Extended Length Tip (K102258) received a 510(k) decision of Substantially Equivalent on June 10, 2011, 304 days after the submission was received.
What is the product code of K102258?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.