Cleared Traditional

Instylla Delivery Kit

K191659 · Instylla, Inc. · General Hospital
Oct 2019
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K191659 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. (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 review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K191659 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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