SoloAsisst II, Voice Control
FDA 510(k) K200473 · Aktormed GmbH
510(k) numberK200473
Submission
- Device name
- SoloAsisst II, Voice Control
- Applicant
- Aktormed GmbH
Barbing, DE - Received
- February 26, 2020
- Decision date
- December 22, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NAY – System, Surgical, Computer Controlled Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K251739 | da Vinci Surgical System (IS5000)NAY · Traditional | Intuitive Surgical, Inc. | 01/16/2026SE |
| K252675 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 12/15/2025SE |
| K252069 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 12/02/2025SE |
| K251426 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 10/03/2025SE |
More from Intuitive Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261573 | Endoscope Holder (182214)QZB · Traditional | 07/20/2026SE |
| K233312 | SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice…QZB · Traditional | 08/08/2024SE |
| K232405 | Endofix ExoOCV · Traditional | 04/25/2024SE |
| K171947 | Soloassist IINAY · Traditional | 09/21/2018SE |
Questions and answers
When was SoloAsisst II, Voice Control cleared by the FDA?
SoloAsisst II, Voice Control (K200473) received a 510(k) decision of Substantially Equivalent on December 22, 2020, 300 days after the submission was received.
What is the product code of K200473?
The FDA product code is NAY – System, Surgical, Computer Controlled Instrument, a Class II (moderate risk) device regulated under 21 CFR 876.1500.