Cleared Traditional

K232405 - ENDOFIX EXO

K232405 is an FDA 510(k) clearance for ENDOFIX EXO, manufactured by Aktormed GmbH. The device is a Class 2 General & Plastic Surgery device with product code OCV cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K232405 · Aktormed GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
259d
Days
Class 2
Risk

K232405 is an FDA 510(k) clearance for the ENDOFIX EXO. Classified as Endoscope Holder (product code OCV), Class II - Special Controls.

Submitted by Aktormed GmbH (Neutraubling, DE). The FDA issued a Cleared decision on April 25, 2024 after a review of 259 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Aktormed GmbH devices

FDA 510(k) Submission Details - K232405

510(k) Number K232405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2023
Decision Date April 25, 2024
Days to Decision 259 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 115d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCV Device Classification - Class 2, Special Controls

Product Code OCV Endoscope Holder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Hold Endoscope In A Desired Position During Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OCV Endoscope Holder

All 8
Devices cleared under the same product code (OCV) and FDA review panel - the closest regulatory comparables to K232405.
KARL STORZ Holders
K240506 · KARL STORZ Endoscopy-America, Inc. · Oct 2024
WalterLorenz Surgical Assist Arm Scope Holder
K190576 · Biomet Microfixation · Jun 2019
ENVIEW (TM)
K102179 · Carefusion 2200 · Dec 2010
V. MUELLER CAMERA CONTROLLER WITH STORAGE CART
K093616 · Carefusion 2200 · Dec 2009
NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
K992006 · Integra Neurocare, LLC · Aug 1999
KSEA ENDOSCOPE HOLDER
K990334 · KARL STORZ Endoscopy-America, Inc. · Mar 1999