K213632 is an FDA 510(k) clearance for the Instylla Delivery Kit. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Instylla, Inc. (Bedford, US). The FDA issued a Cleared decision on February 10, 2022, 85 days after receiving the submission on November 17, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K213632 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2021 |
| Decision Date | February 10, 2022 |
| Days to Decision | 85 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 |