Cleared Traditional

ERBEJET? 2 System

K231023 · Erbe Elektromedizin GmbH · General & Plastic Surgery
Jun 2023
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K231023 is an FDA 510(k) clearance for the ERBEJET? 2 System, a Lavage, Jet (Class II — Special Controls, product code FQH), submitted by Erbe Elektromedizin GmbH (Tuebingen, DE). The FDA issued a Cleared decision on June 15, 2023, 65 days after receiving the submission on April 11, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5475.

Submission Details

510(k) Number K231023 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2023
Decision Date June 15, 2023
Days to Decision 65 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FQH — Lavage, Jet
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5475

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