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FDA 510(k)

ENDOSCOPE HOLDER (182214)

K-Number: K261573 · 2026-07-20

ApplicantAktormed GmbH
Decision Date2026-07-20
Product CodeQZB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPE HOLDER (182214) is the device name listed in this FDA 510(k) record. The listed applicant is Aktormed GmbH. It received FDA 510(k) clearance on 2026-07-20 under 510(k) number K261573. 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 ENDOSCOPE HOLDER (182214)?

ENDOSCOPE HOLDER (182214) is a medical device that received FDA 510(k) clearance on 2026-07-20. The listed applicant is Aktormed GmbH. The 510(k) number is K261573.

When did ENDOSCOPE HOLDER (182214) receive FDA 510(k) clearance?

ENDOSCOPE HOLDER (182214) received FDA 510(k) clearance on 2026-07-20, under 510(k) number K261573.

Who is the listed applicant for ENDOSCOPE HOLDER (182214)?

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 ENDOSCOPE HOLDER (182214)?

The FDA product code for ENDOSCOPE HOLDER (182214) 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.

K233312SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894K232405ENDOFIX 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.

K250984Maestro System (REF100)Moon SurgicalK242323Maestro System (REF100)Moon SurgicalK233312SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894Aktormed GmbH

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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