510(k) K261573
K261573 is an FDA 510(k) premarket notification submitted by Aktormed GmbH for the device "ENDOSCOPE HOLDER (182214)". The FDA issued a decision of Substantially Equivalent on July 20, 2026. The device falls under product code QZB (Software Controlled Endoscope And Instrument Holder), a Class II device regulated under 21 CFR 876.1500. Aktormed GmbH has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2026
- Date Received
- May 12, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Software Controlled Endoscope And Instrument Holder
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type
To hold and position endoscopes and instruments.