Skip to content

Erbe APC Integrated Filter Probes; Erbe APC Integrated Filter Probe Adapter

by Erbe USA, Inc. 510(k)

Active United States

510(k) K060183

Overview

The device is an argon plasma coagulation (APC) probe with an integrated filter, designed for use in endoscopic procedures to coagulate bleeding sites and ablate tissue. It is a single-use probe that includes a proprietary coating for improved heat conductivity and reduced tissue sticking at high temperatures.

The probe is supplied sterile and ready for immediate use in the operating room, eliminating the need for cable preparation. It connects to the APC module via an ergonomic plug design that allows for visual identification of the integrated filter. The device is authorized under FDA 510(k) clearance K060183.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK060183 Date16 Feb 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Erbe USA, Inc.

See all devices from Erbe USA, Inc. →

Questions

  • What is the ERBE APC Integrated Filter Probe used for?

    The ERBE APC Integrated Filter Probe is designed for use in endoscopic procedures to coagulate bleeding sites and ablate tissue. It delivers argon plasma coagulation (APC) energy through a probe with an integrated filter, enabling precise tissue treatment during endoscopy. The proprietary coating improves heat conductivity and reduces tissue sticking at high temperatures, enhancing procedural efficiency and safety.

  • Is the ERBE APC Integrated Filter Probe sterile and single-use?

    Yes, the probe is supplied sterile and ready for immediate use in the operating room, eliminating the need for cable preparation or additional sterilization steps. It is designed as a single-use device, meaning it is intended for one procedure only and should be discarded after use to prevent cross-contamination and ensure consistent performance.

  • How does the ERBE APC Integrated Filter Probe connect to the APC module?

    The probe connects to the APC module via an ergonomic plug design that allows for visual identification of the integrated filter. This design ensures secure and correct attachment while enabling clinicians to confirm the presence of the filter before use, supporting safe and efficient setup during endoscopic procedures.

  • What regulatory authorization does the ERBE APC Integrated Filter Probe have?

    The device is authorized under FDA 510(k) clearance K060183, which was granted on February 16, 2006, following a determination of substantial equivalence to a legally marketed predicate device. This clearance permits its commercial distribution in the United States for the intended endoscopic coagulation and ablation uses.