K173184 is an FDA 510(k) clearance for the Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle, a Endoscopic Ultrasound System, Gastroenterology-urology (Class II — Special Controls, product code ODG), submitted by Boston Scientific (Marborough, US). The FDA issued a Cleared decision on October 27, 2017, 28 days after receiving the submission on September 29, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K173184 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2017 |
| Decision Date | October 27, 2017 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODG — Endoscopic Ultrasound System, Gastroenterology-urology |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. 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). |