510(k) K183636
K183636 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller". The FDA issued a decision of Substantially Equivalent on January 22, 2019. The device falls under product code FBN (Choledochoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2019
- Date Received
- December 26, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Choledochoscope And Accessories, Flexible/Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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).