Rosa Surgical Device, Model Rosa 1.1

510(k) K092239

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

9 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK092239	Date17 Nov 2009Cleared	StatusActive

9 recalls · FDA

- Terminated Z-3117-2017 FDA Class II initiated 20 Jan 2016
Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
- Terminated Z-0160-2018 FDA Class II initiated 6 Nov 2014
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
- Terminated Z-0184-2018 FDA Class II initiated 5 Sep 2014
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
- Terminated Z-0161-2018 FDA Class II initiated 4 Jun 2014
Software corrections reactivating the cooperative endoscopy mode.
- Terminated Z-0102-2018 FDA Class II initiated 14 Feb 2014
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
- Terminated Z-0096-2018 FDA Class II initiated 18 Dec 2013
Possible break in the connector of the Force Sensor.
- Terminated Z-0178-2018 FDA Class II initiated 10 Feb 2013
Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
- Terminated Z-0099-2018 FDA Class II initiated 5 Feb 2013
Observed instability of the device.
- Terminated Z-0100-2018 FDA Class II initiated 19 Apr 2012
Potential failure of the optical distance sensor due to cable disconnection.

1 jurisdiction

United States — FDA 510(k) Active

510(k)