K200629 is an FDA 510(k) clearance for the Aspire Mechanical Aspirator G. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Control Medical Technology (Salt Lake City, US). The FDA issued a Cleared decision on May 29, 2020, 80 days after receiving the submission on March 10, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K200629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2020 |
| Decision Date | May 29, 2020 |
| Days to Decision | 80 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |