K212696 is an FDA 510(k) clearance for the Aspira Pleural Drainage System. This device is classified as a Apparatus, Suction, Patient Care (Class II - Special Controls, product code DWM).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on March 3, 2023, 555 days after receiving the submission on August 25, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.5050.
| 510(k) Number | K212696 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2021 |
| Decision Date | March 03, 2023 |
| Days to Decision | 555 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DWM — Apparatus, Suction, Patient Care |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5050 |