Cleared Traditional

Talee, Talee PostOp

K241957 · Invent Medical USA, LLC · Neurology
Aug 2024
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K241957 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 August 30, 2024, 58 days after receiving the submission on July 3, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5970.

Submission Details

510(k) Number K241957 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2024
Decision Date August 30, 2024
Days to Decision 58 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