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FDA 510(k)

ENDOFIX EXO

K-Number: K232405 · 2024-04-25

ApplicantAktormed GmbH
Decision Date2024-04-25
Product CodeOCV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOFIX EXO is a medical device manufactured by Aktormed GmbH. It received FDA 510(k) clearance on 2024-04-25 under approval number K232405. The device is classified under product code OCV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOFIX EXO?

ENDOFIX EXO is a medical device that received FDA 510(k) clearance on 2024-04-25. It is manufactured by Aktormed GmbH. The 510(k) number is K232405.

When was ENDOFIX EXO approved by the FDA?

ENDOFIX EXO received FDA 510(k) clearance on 2024-04-25, under approval number K232405.

What company makes ENDOFIX EXO?

ENDOFIX EXO is manufactured by Aktormed GmbH.

What is the FDA product code for ENDOFIX EXO?

The FDA product code for ENDOFIX EXO is OCV.

Other Devices by Aktormed GmbH

K171947SOLOASSIST II K200473SoloAsisst II, Voice Control K233312SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894

Related Devices (Code: OCV)

K190576WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation K240506KARL STORZ HoldersKarl Storz Endoscopy America, Inc.

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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