Stellartech Coagulation System, Models 1100C-115A & 1100C-230A

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K042909 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)

  Class II

  FDA 510(k) K032721 Active Cleared 6 Oct 2003

• Stellartech Coagulation System (Models 1100C-115 & 1100C-230)

  Class II

  FDA 510(k) K040240 Active Cleared 1 Apr 2004

• Stellartech 100 Coagulation System

  Class II

  FDA 510(k) K061544 Active Cleared 13 Oct 2006

• Stellartech Radiofrequency Generator, Model 1025A-115, Stellartech Radiofrequency Generator, Model 1025A-230

  Class II

  FDA 510(k) K994173 Active Cleared 20 Jan 2000

• Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230

  Class II

  FDA 510(k) K032452 Active Cleared 21 Aug 2003

• Stellartech Coagulation System, Models 1100C-115 and 1100C-230

  Class II

  FDA 510(k) K041383 Active Cleared 14 Jun 2004

See all devices from Stellartech Research Corp. →

• What is the Stellartech Coagulation System used for?

  The Stellartech Coagulation System is an electrosurgical device designed for coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including the esophagus. It is intended for use in general and plastic surgery applications.

• What components are included with the Stellartech Coagulation System?

  The system includes a coagulation catheter, generator, connection cable, and optional components such as a sheath, footswitch, and sizing catheter. It is supplied as a reusable system and is not specified as MRI safe.

• What is the regulatory status of the Stellartech Coagulation System?

  The device is authorized under FDA 510K clearance with product code GEI. It was cleared on November 12, 2004, and is classified under the Special clearance type with a decision code of SESE, indicating it is substantially equivalent to predicate devices.

• How should the Stellartech Coagulation System be stored?

  The device data does not specify storage requirements. As a reusable electrosurgical device, it should be stored according to the manufacturer's instructions to maintain functionality and safety, typically in a clean, dry environment away from extreme temperatures or physical damage.