510(k) K181439
K181439 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "SpyGlass DS and DS II Direct Visualization System". The FDA issued a decision of Substantially Equivalent on August 23, 2018. 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
- August 23, 2018
- Date Received
- June 1, 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).