K181439 is an FDA 510(k) clearance for the SpyGlass DS and DS II Direct Visualization System. This device is classified as a Choledochoscope And Accessories, Flexible/rigid (Class II - Special Controls, product code FBN).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on August 23, 2018, 83 days after receiving the submission on June 1, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. 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)..
| 510(k) Number | K181439 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2018 |
| Decision Date | August 23, 2018 |
| Days to Decision | 83 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FBN — Choledochoscope And Accessories, Flexible/rigid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | 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). |