# K243120: HybridAPC probe

- Pathway: 510(k) (Traditional)
- Applicant: Erbe Elektromedizin GmbH
- Decided: Jun 20, 2025 after 263 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K952726 (1995). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143306: ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe, Erbe USA, Inc. (2015) Summary page 5.
- K060183: Erbe Apc Integrated Filter Probes; Erbe Apc Integrated Filter Probe Adapter, Erbe USA, Inc. (2006) Summary page 5.

## Most influential descendants
- K253915: MOVIVA® Hybrid Ablation Probe (2025), 0 descendants of its own

## 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

Source page: https://510kreport.com/device/K243120
Methodology: https://510kreport.com/methodology