Mentor Ultrasound Assisted Tissue Removal System (TRS)
FDA 510(k) K970471 · Mentor Corp.
510(k) numberK970471
Submission
- Device name
- Mentor Ultrasound Assisted Tissue Removal System (TRS)
- Applicant
- Mentor Corp.
Santa Barbara, CA, US - Received
- February 7, 1997
- Decision date
- July 17, 1997
- 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
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|---|---|---|---|
| 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 |
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| K050008 | Mentor Self-Cath Hydrogel Intermittent CatheterEZD · Traditional | 06/03/2005SE |
| K050148 | Mentor Aris Trans-Obturator Tape and Surgical KitOTN · Traditional | 03/09/2005SE |
| K042851 | Mentor Obtape Trans-Obturator Surgical KitOTN · Special | 11/09/2004SE |
| K040959 | Mentor Genesis Penile ProsthesisFAE · Traditional | 10/29/2004SE |
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Questions and answers
When was Mentor Ultrasound Assisted Tissue Removal System (TRS) cleared by the FDA?
Mentor Ultrasound Assisted Tissue Removal System (TRS) (K970471) received a 510(k) decision of Substantially Equivalent on July 17, 1997, 160 days after the submission was received.
What is the product code of K970471?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.