Cleared Special

Instylla Delivery Kit

K253769 · Instylla, Inc. · General Hospital
Dec 2025
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K253769 is an FDA 510(k) clearance for the Instylla Delivery Kit, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Instylla, Inc. (Bedford, US). The FDA issued a Cleared decision on December 22, 2025, 27 days after receiving the submission on November 25, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K253769 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2025
Decision Date December 22, 2025
Days to Decision 27 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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