LOTUS Series 4 Enhanced Shears, LOTUS Series 5
FDA 510(k) K221102 · Sra Developments, Ltd.
510(k) numberK221102
Submission
- Device name
- LOTUS Series 4 Enhanced Shears, LOTUS Series 5
- Applicant
- Sra Developments, Ltd.
Ashburton, GB - Received
- April 14, 2022
- Decision date
- December 15, 2022
- 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 |
|---|---|---|
| K151101 | Lotus Series 4 Ultrasonic Surgical System & AccessoriesLFL · Special | 07/17/2015SE |
| K072961 | Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)JDX · Traditional | 12/19/2007SE |
| K063531 | Series 3 Lotus Laparoscopic Ultrasound Surgery SystemLFL · Traditional | 02/22/2007SE |
| K032424 | LotusLFL · Traditional | 12/16/2003SE |
Questions and answers
When was LOTUS Series 4 Enhanced Shears, LOTUS Series 5 cleared by the FDA?
LOTUS Series 4 Enhanced Shears, LOTUS Series 5 (K221102) received a 510(k) decision of Substantially Equivalent on December 15, 2022, 245 days after the submission was received.
What is the product code of K221102?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.