SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499) +2 more— 510(k) K233312

Name: FDA 510(k) clearance K233312
Creator: U.S. Food and Drug Administration
Published: 2024-08-08

Substantially Equivalent

Aktormed GmbH

FDA 510(k) clearance K233312 for SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499) +2 more, Substantially Equivalent on 2024-08-08. Applicant: Aktormed GmbH. Device class: 2.

Clearance details

Device name as filed: SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894
Applicant: Aktormed GmbH
Product code: Code QZB
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-09-29
Decision date: 2024-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neutraubling, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code QZB

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K261573 — ENDOSCOPE HOLDER (182214)2026-07-20
K250984 — Maestro System (REF100)2025-06-27
K242323 — Maestro System (REF100)2025-03-14

More clearances from Aktormed GmbH

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K232405 — ENDOFIX EXO2024-04-25
K200473 — SoloAsisst II, Voice Control2020-12-22
K171947 — SOLOASSIST II2018-09-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.