FDA 510(k)

ENDOFIX EXO

K-Number: K232405 · 2024-04-25

Decision Date2024-04-25

Product CodeOCV

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ENDOFIX EXO is the device name listed in this FDA 510(k) record. The listed applicant is Aktormed GmbH. It received FDA 510(k) clearance on 2024-04-25 under 510(k) 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. The listed applicant is Aktormed GmbH. The 510(k) number is K232405.

When did ENDOFIX EXO receive FDA 510(k) clearance?

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

Who is the listed applicant for ENDOFIX EXO?

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 ENDOFIX EXO?

The FDA product code for ENDOFIX EXO is OCV.

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

Related Devices (Code: OCV)

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

Official Source

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