Manufacturer
Erbe Elektromedizin GmbHHybridAPC probe
Country / Region:United States (US)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K243120
- Device name
- HybridAPC probe
- Company
- Erbe Elektromedizin GmbH
- 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
9Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K243120 as a predicate
