Cleared Traditional

K231023 - ERBEJET® 2 System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231023 · Erbe Elektromedizin GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
65d
Days
Class 2
Risk

K231023 is an FDA 510(k) clearance for the ERBEJET® 2 System. Classified as Lavage, Jet (product code FQH), Class II - Special Controls.

Submitted by Erbe Elektromedizin GmbH (Tuebingen, DE). The FDA issued a Cleared decision on June 15, 2023 after a review of 65 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5475 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Erbe Elektromedizin GmbH devices

Submission Details

510(k) Number K231023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 114d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FQH Lavage, Jet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5475
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FQH Lavage, Jet

All 52
Devices cleared under the same product code (FQH) and FDA review panel - the closest regulatory comparables to K231023.
BD Surgiphor™ Antimicrobial Irrigation System (910110)
K253996 · Becton, Dickinson and Company (BD) · Feb 2026
BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)
K253445 · Bd · Feb 2026
Armis VeriCyn Wound Wash
K220759 · Armis Biopharma, Inc. · May 2023
VERSAJET Hydrosurgery System (III)
K220964 · Smith & Nephew Medical Limited · May 2023
BD Surgiphor™ Antimicrobial Irrigation System
K221504 · Bd · Oct 2022
Irrisept Antimicrobial Wound Lavage
K222804 · Irrimax Corporation · Sep 2022