Cleared Traditional

K261573 - ENDOSCOPE HOLDER (182214)

K261573 is the FDA 510(k) clearance for ENDOSCOPE HOLDER (182214) by Aktormed GmbH. It is a Class 2 General & Plastic Surgery device (product code QZB) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K261573 · Aktormed GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
69d
Days
Class 2
Risk

K261573 is an FDA 510(k) clearance for the ENDOSCOPE HOLDER (182214). Classified as Software Controlled Endoscope And Instrument Holder (product code QZB), Class II - Special Controls.

Submitted by Aktormed GmbH (Neutraubling, DE). The FDA issued a Cleared decision on July 20, 2026 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aktormed GmbH devices

Submission Details

510(k) Number K261573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2026
Decision Date July 20, 2026
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QZB Software Controlled Endoscope And Instrument Holder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Hold And Position Endoscopes And Instruments.
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.