Cleared Traditional

K220681 - Talee, Talee PostOP
(FDA 510(k) Clearance)

K220681 · Invent Medical USA, LLC · Neurology
Sep 2022
Decision
198d
Days
Class 2
Risk

K220681 is an FDA 510(k) clearance for the Talee, Talee PostOP, a Orthosis, Cranial (Class II — Special Controls, product code MVA), submitted by Invent Medical USA, LLC (Warminster, US). The FDA issued a Cleared decision on September 22, 2022, 198 days after receiving the submission on March 8, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5970.

Submission Details

510(k) Number K220681 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2022
Decision Date September 22, 2022
Days to Decision 198 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