Manufacturer
Erbe Elektromedizin GmbHFiAPC plus probes
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
- K243451
- Device name
- FiAPC plus probes
- Company
- Erbe Elektromedizin GmbH
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2024-11-07
- Decision date
- 2025-03-21
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryTissue Repair
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The flexible FiAPC probes are intended for argon plasma coagulation and ablation of tissue.
Intended Use
The flexible FiAPC probes are intended for argon plasma coagulation and ablation of tissue.
Device Description
The FiAPC® plus probes are sterile, single-use flexible probes intended for argon plasma coagulation (APC) and ablation of tissue. The probes have a plug on the proximal end that enables the connection to the compatible electrosurgical unit (ESU) and APC unit. The plug is ergonomically designed and contains a filter that isolates the device side from the patient side. The plug also contains an instrument recognition which ensures that the instrument can only be operated with the compatible parent devices. The connector is followed by a long tube so that the probe can be inserted into the working channel of an endoscope. At the distal end there is an opening through which the argon plasma is released. The flexible FiAPC® plus probes are available in different variants. All variants have the same outer diameter but differ in their length and distal opening.
Summary parsed at:2026-06-20 17:53:33 UTC