510(k) K163614
K163614 is an FDA 510(k) premarket notification submitted by Pentax Medical for the device "PENTAX Medical ED34-i10T, Video Duodenoscope". The FDA issued a decision of Substantially Equivalent on September 20, 2017. The device falls under product code FDT (Duodenoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Pentax Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2017
- Date Received
- December 22, 2016
- 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).