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FDA 510(k)

SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894

K-Number: K233312 · 2024-08-08

ApplicantAktormed GmbH
Decision Date2024-08-08
Product CodeQZB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 is the device name listed in this FDA 510(k) record. The listed applicant is Aktormed GmbH. It received FDA 510(k) clearance on 2024-08-08 under 510(k) number K233312. The device is classified under product code QZB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894?

SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 is a medical device that received FDA 510(k) clearance on 2024-08-08. The listed applicant is Aktormed GmbH. The 510(k) number is K233312.

When did SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 receive FDA 510(k) clearance?

SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 received FDA 510(k) clearance on 2024-08-08, under 510(k) number K233312.

Who is the listed applicant for SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894?

The FDA 510(k) record lists Aktormed GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894?

The FDA product code for SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 is QZB.

Other records listing Aktormed GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261573ENDOSCOPE HOLDER (182214)K232405ENDOFIX EXOK200473SoloAsisst II, Voice ControlK171947SOLOASSIST II

Related Devices (Code: QZB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261573ENDOSCOPE HOLDER (182214)Aktormed GmbHK250984Maestro System (REF100)Moon SurgicalK242323Maestro System (REF100)Moon Surgical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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