Decision Date2025-03-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
FiAPC plus probes is a medical device manufactured by Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2025-03-21 under approval number K243451. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FiAPC plus probes?
FiAPC plus probes is a medical device that received FDA 510(k) clearance on 2025-03-21. It is manufactured by Erbe Elektromedizin GmbH. The 510(k) number is K243451.
When was FiAPC plus probes approved by the FDA?
FiAPC plus probes received FDA 510(k) clearance on 2025-03-21, under approval number K243451.
What company makes FiAPC plus probes?
FiAPC plus probes is manufactured by Erbe Elektromedizin GmbH.
What is the FDA product code for FiAPC plus probes?
The FDA product code for FiAPC plus probes is GEI.
Other Devices by Erbe Elektromedizin GmbH
K150364ERBE ESU Model VIO dV with Accessories
K191234APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets
K190823Erbe ESU Model VIO 3 with Accessories
K183445Erbe APCapplicators
K190651ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter
K232033HYBRIDknife® flex
View all 14 devices →
Related Devices (Code: GEI)
Official Source
View on FDA Database →
Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.