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Erbotom ICC 200

by Erbe USA, Inc. 510(k)

Active United States

510(k) K933157

Overview

The Erbotom ICC 200 is an electrosurgical unit designed for use in general and plastic surgery procedures. It provides electrocautery functionality for cutting and coagulating tissue during surgical interventions.

The device is supplied as a reusable electrosurgical workstation for flexible endoscopy and is authorized under FDA 510(k) clearance K933157. It operates with a power output of more than 200 watts and includes multiple coagulation and cutting modes such as Auto Cut, Endo Cut, Forced Coagulation, Soft Coagulation, and Bipolar Coagulation.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK933157 Date23 Feb 1994ClearedStatusActive

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
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Erbotom ICC 200 used for?

    The Erbotom ICC 200 is designed for use in general and plastic surgery procedures, providing electrocautery functionality for cutting and coagulating tissue during surgical interventions.

  • How is the Erbotom ICC 200 supplied and is it reusable?

    The device is supplied as a reusable electrosurgical workstation for flexible endoscopy, meaning it is intended for multiple uses after proper cleaning and sterilization between procedures.

  • What power output and modes does the Erbotom ICC 200 offer?

    The Erbotom ICC 200 operates with a power output of more than 200 watts and includes multiple coagulation and cutting modes such as Auto Cut, Endo Cut, Forced Coagulation, Soft Coagulation, and Bipolar Coagulation.