Sharplan 4300 & 4310 Ultrasonic Surgical Apirators
FDA 510(k) K883091 · Sharplan Lasers, Inc.
510(k) numberK883091
Submission
- Device name
- Sharplan 4300 & 4310 Ultrasonic Surgical Apirators
- Applicant
- Sharplan Lasers, Inc.
Allendale, NJ, US - Received
- July 22, 1988
- Decision date
- October 14, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K973354 | Sharplan Epitouch Alexandrite Laser System (5000)GEX · Traditional | 12/04/1997SE |
| K972099 | Sharplan Epitouch Ruby Laser SystemGEX · Traditional | 08/27/1997SE |
| K971874 | Sharplan Epitouch Alexandrite Laser System (5000)GEX · Traditional | 08/18/1997SE |
| K971648 | Sharplan Erbium: Yag Laser (4020)GEX · Traditional | 07/23/1997SE |
| K971743 | Sharplan CO2 Surgical Laser SystemGEX · Traditional | 07/18/1997SE |
| K962446 | Sharplan Ruby Laser SystemGEX · Traditional | 03/07/1997SE |
| K963229 | Sharplan Models 20C, 30C, and 40C CO2 LasersGEX · Traditional | 11/05/1996SE |
| K961935 | Sharplan Lasers, Inc. Silktouch CO2 Flash ScannerGEX · Traditional | 11/01/1996SE |
| K962974 | Sharplan Lasers, Inc. Af Acuspot Micromanipulator (713)GEX · Traditional | 08/21/1996SE |
| K961279 | Sharplan Lasers, Inc. Ruby Laser SystemGEX · Traditional | 06/18/1996SE |
Questions and answers
When was Sharplan 4300 & 4310 Ultrasonic Surgical Apirators cleared by the FDA?
Sharplan 4300 & 4310 Ultrasonic Surgical Apirators (K883091) received a 510(k) decision of Substantially Equivalent on October 14, 1988, 84 days after the submission was received.
What is the product code of K883091?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.