Cleared Traditional

K233312 - SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499) (FDA 510(k) Clearance)

Also includes:
ARTip solo (202426) + ARTip solo voice (202445) SOLOASSIST II (141364) + VOICE CONTROL (171894

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233312 · Aktormed GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
314d
Days
Class 2
Risk

K233312 is an FDA 510(k) clearance for the SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499). 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 August 8, 2024 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K233312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date August 08, 2024
Days to Decision 314 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
200d slower than avg
Panel avg: 114d · This submission: 314d
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.