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HybridAPC probe

Erbe Elektromedizin GmbH

Country / Region:United States (US)Submission type:Traditional

Product code GEI· 21 CFR 878.4400

Summary PDF

Company

United States (US)

Product code

GEI
21 CFR 878.4400

Predicate devices

9

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K243120
Device name
HybridAPC probe
Country / Region
United States(US)
Product code
GEI
Device class
Class 2
Regulation number
21 CFR 878.4400
Date received
2024-09-30
Decision date
2025-06-20
Submission type
Traditional
Technology type
RF Ablation(AI inferred)
Clinical applications
SurgeryTissue RepairPain ManagementOther
Primary application
Surgery
Classification source
AI classified

Indications for Use

The HybridAPC probe is intended for the submucosal injection of sterile normal saline to lift mucosa using direct visualization through an endoscope and for HF ablation of the mucosa, with or without lesions, by Argon Plasma Coagulation (APC). Indications include but are not limited to:
• Barrett's esophagus
• Ulcers
• Arteriovenous Malformations
• Angioma
• Angiodysplasia
• Gastric Antral Vascular Ectasia (GAVE)
• Radiation Proctitis
• Gastroesophageal reflux disease (GERD)
• Post-polypectomy ablation/Post-EMR ablation

Intended Use

The HybridAPC probe is intended for the submucosal injection of sterile normal saline to lift mucosa using direct visualization through an endoscope and for HF ablation of the mucosa, with or without lesions, by Argon Plasma Coagulation (APC). Indications include but are not limited to: Barrett's esophagus, Ulcers, Arteriovenous Malformations, Angioma, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE), Radiation Proctitis, Gastroesophageal reflux disease (GERD), Post-polypectomy ablation/Post-EMR ablation.

Device Description

The HybridAPC probe is a flexible, sterile, single use monopolar probe that combines the technologies of hydrosurgery and argon plasma coagulation (APC) in one instrument. Each function can be activated independently without the need to change instruments. It is used with the hydrosurgical unit Model ERBEJET 2 and an Erbe APC unit in combination with an electrosurgical unit (ESU) VIO Model. The probe is used with endoscopes with a working channel diameter larger than 2.5mm. The hydrosurgical function is intended to deliver a pressurized fluid to create a fluid cushion beneath the mucosa/mucosal lesion to be ablated which serves as a mechanical and thermal protection layer for the underlying tissue and to reduce the risk of perforations. The electrosurgical (i.e. APC) function is intended for ablation of the lifted mucosa/mucosal lesion. The Hybrid APC probe has a length of 1.9 meters and an outer diameter (OD) of 2.3mm. The HybridAPC probe is connected to the units via respective cables/tubings. The settings or adjustment of application parameters is performed via the units. Activation of the instrument is done using a footswitch.

Summary parsed at:2026-06-20 17:45:54 UTC

Predicate devices

9

K243120 references 9 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K243120 as a predicate