Maestro Platform
FDA 510(k) K221410 · Moon Surgical
510(k) numberK221410
Submission
- Device name
- Maestro Platform
- Applicant
- Moon Surgical
Paris, FR - Received
- May 16, 2022
- Decision date
- December 2, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FQO – Table, Operating-Room, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240598 | Maestro System (REF100)FQO · Traditional | Moon Surgical | 06/03/2024SE |
| K090136 | Steris Cmax XLT Surgical TableFQO · Traditional | STERIS Corporation | 03/20/2009SE |
| K972810 | OPT80 the Transportable (OPT80)FQO · Traditional | O.P.T. USA, Inc. | 08/26/1997SE |
| K971988 | Allen, Ultra and Smart SocketsFQO · Traditional | Allen Medical Systems, Inc. | 07/11/1997SE |
| K971307 | Amsco Surgical TableFQO · Traditional | STERIS Corporation | 06/27/1997SE |
| K963506 | Tenet Radiolucent Hand TableFQO · Traditional | Tenet Medical Engineering | 01/09/1997SE |
| K961886 | Drager Gemina Wall-Mounted WorkplaceFQO · Traditional | Alm Surgical Equipment, Inc. | 07/30/1996SE |
| K961742 | Drager Dve 8080/81/82 with Dve 4002 or Dve 4001 Series SystemFQO · Traditional | Alm Surgical Equipment, Inc. | 07/26/1996SE |
| K955750 | TeletomFQO · Traditional | Berchtold Holding GmbH | 02/08/1996SE |
| K953980 | Kreuzer Ceiling Mounted Support Systems, KlinoportFQO · Traditional | Kreuzer Corp. | 11/16/1995SE |
More from Kreuzer Corp.
Questions and answers
When was Maestro Platform cleared by the FDA?
Maestro Platform (K221410) received a 510(k) decision of Substantially Equivalent on December 2, 2022, 200 days after the submission was received.
What is the product code of K221410?
The FDA product code is FQO – Table, Operating-Room, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.