K210782 is an FDA 510(k) clearance for the Tablo Cartridge, a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II — Special Controls, product code FJK), submitted by Outset Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on November 26, 2021, 255 days after receiving the submission on March 16, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K210782 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 16, 2021 |
| Decision Date | November 26, 2021 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJK — Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |