ENDOSCOPE HOLDER (182214)— 510(k) K261573
Substantially EquivalentAktormed GmbH
FDA 510(k) clearance K261573 for ENDOSCOPE HOLDER (182214), Substantially Equivalent on 2026-07-20. Applicant: Aktormed GmbH. Device class: 2.
Summary
Aktormed's ENDOSCOPE HOLDER (182214) is filed under QZB, software controlled endoscope and instrument holders. The record gives the model as 182214 but no specs.
Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.
Aktormed filed from Neutraubling, Germany. Review took 69 calendar days (May 12 to July 20, 2026).
Clearance details
- Applicant
- Aktormed GmbH
- Product code
- Product code QZB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Neutraubling, DE
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