K253769
- 510(k) number
- K253769
- Device name
- Instylla Delivery Kit
- Applicant
- Instylla, Inc. MA · US
- Product code
- FMF — Syringe, Piston
- Decision date
- 2025-12-22
- Date received
- 2025-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253769.pdf
Official FDA record: K253769
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.