Cleared Special

Instylla Delivery Kit

K213632 · Instylla, Inc. · General Hospital
Feb 2022
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K213632 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 February 10, 2022, 85 days after receiving the submission on November 17, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K213632 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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