K213195 is an FDA 510(k) clearance for the Balloon BS-3, a Enteroscope And Accessories (Class II — Special Controls, product code FDA), submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on October 29, 2021, 30 days after receiving the submission on September 29, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K213195 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2021 |
| Decision Date | October 29, 2021 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDA — Enteroscope And Accessories |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Provide Visualization And Perform Various Procedures Within The Small Intestine. 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). |