TX1 Tissue Removal System
FDA 510(k) K101561 · American Optisurgical, Inc.
510(k) numberK101561
Submission
- Device name
- TX1 Tissue Removal System
- Applicant
- American Optisurgical, Inc.
Lake Forest, CA, US - Received
- June 4, 2010
- Decision date
- August 27, 2010
- 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
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| 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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Questions and answers
When was TX1 Tissue Removal System cleared by the FDA?
TX1 Tissue Removal System (K101561) received a 510(k) decision of Substantially Equivalent on August 27, 2010, 84 days after the submission was received.
What is the product code of K101561?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.