ERBEJET® 2 System

FDA 510(k) K231023 · Erbe Elektromedizin GmbH

Substantially Equivalent

510(k) numberK231023

Submission

Device name
ERBEJET® 2 System
Applicant
Erbe Elektromedizin GmbH
Tuebingen, DE
Received
April 11, 2023
Decision date
June 15, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FQH – Lavage, Jet
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5475
Specialty
General Hospital

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Questions and answers

When was ERBEJET® 2 System cleared by the FDA?

ERBEJET® 2 System (K231023) received a 510(k) decision of Substantially Equivalent on June 15, 2023, 65 days after the submission was received.

What is the product code of K231023?

The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.