Cleared Traditional

SnugKap

K193383 · Headstart, Ltd. · Neurology
Jun 2021
Decision
550d
Days
Class 2
Risk

About This 510(k) Submission

K193383 is an FDA 510(k) clearance for the SnugKap, a Orthosis, Cranial (Class II — Special Controls, product code MVA), submitted by Headstart, Ltd. (Elk Grove Village, US). The FDA issued a Cleared decision on June 7, 2021, 550 days after receiving the submission on December 5, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5970.

Submission Details

510(k) Number K193383 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2019
Decision Date June 07, 2021
Days to Decision 550 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MVA — Orthosis, Cranial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5970