Cleared Traditional

TrabEx Pro

K213173 · Microsurgical Technologies, Inc. · Ophthalmic
Jun 2022
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K213173 is an FDA 510(k) clearance for the TrabEx Pro, a Pump, Infusion, Ophthalmic (Class II — Special Controls, product code MRH), submitted by Microsurgical Technologies, Inc. (Redmond, US). The FDA issued a Cleared decision on June 8, 2022, 253 days after receiving the submission on September 28, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K213173 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2021
Decision Date June 08, 2022
Days to Decision 253 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MRH — Pump, Infusion, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725