510(k) K201098
K201098 is an FDA 510(k) premarket notification submitted by Ambu Innovation GmbH for the device "Ambu Duodeno System". The FDA issued a decision of Substantially Equivalent on July 17, 2020. The device falls under product code FDT (Duodenoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2020
- Date Received
- April 24, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Duodenoscope And Accessories, Flexible/Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).