K231096 is an FDA 510(k) clearance for the Automatic Continuous Effusion Shunt (ACES) System ACES System. This device is classified as a Shunt, Peritoneal (Class II - Special Controls, product code KPM).
Submitted by Pleural Dynamics, Inc. (Wayzata, US). The FDA issued a Cleared decision on August 18, 2023, 122 days after receiving the submission on April 18, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5955.
| 510(k) Number | K231096 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2023 |
| Decision Date | August 18, 2023 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPM - Shunt, Peritoneal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5955 |