Soring GmbH Sonoca 180/190
FDA 510(k) K012753 · Soring GmbH Medizintechnik
510(k) numberK012753
Submission
- Device name
- Soring GmbH Sonoca 180/190
- Applicant
- Soring GmbH Medizintechnik
Denton, TX, US - Received
- August 16, 2001
- Decision date
- November 13, 2001
- 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 |
|---|---|---|
| K093511 | Soring MBC200/BCC140GEI · Traditional | 04/16/2010SE |
| K052183 | Soring GmbH Sonoca LipoQPB · Traditional | 10/07/2005SE |
| K030028 | CPC by Soring GmbHGEI · Special | 01/17/2003SE |
| K024059 | MBC SeriesGEI · Special | 01/08/2003SE |
| K993265 | Soring GmbH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600GEI · Special | 10/22/1999SE |
| K992026 | Soring GmbH, Sonoca 300BTA · Traditional | 09/23/1999SE |
Questions and answers
When was Soring GmbH Sonoca 180/190 cleared by the FDA?
Soring GmbH Sonoca 180/190 (K012753) received a 510(k) decision of Substantially Equivalent on November 13, 2001, 89 days after the submission was received.
What is the product code of K012753?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.