K191659 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. (Waltham, US). The FDA issued a Cleared decision on October 10, 2019, 111 days after receiving the submission on June 21, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K191659 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2019 |
| Decision Date | October 10, 2019 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| 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 |