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

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

510(k) Number

K041383 ↗

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 & 1100C-230)

  Class II

  FDA 510(k) K032062 Active Cleared 29 Jul 2003

See all devices from Stellartech Research Corp. →

• What is the Stellartech Coagulation System, Models 1100C-115 and 1100C-230 used for?

  The Stellartech Coagulation System is designed specifically for endoscopic coagulation to achieve hemostasis (stopping bleeding) in the gastrointestinal tract. It targets conditions such as esophageal ulcers, arteriovenous malformations (AVMs), and Dieulafoy lesions, delivering controlled thermal energy through a specialized probe to minimize blood loss during procedures.

• How is the Stellartech Coagulation System supplied and prepared for use?

  This device is supplied as a reusable medical instrument, meaning it must undergo thorough sterilization between uses to ensure safety and efficacy. It is intended for clinical settings like endoscopy suites or operating rooms, where proper sterilization protocols must be followed to maintain its functionality and sterility.

• Is the Stellartech Coagulation System single-use or reusable?

  The Stellartech Coagulation System is explicitly designed as a reusable device. This classification requires adherence to strict sterilization procedures between uses to prevent cross-contamination and ensure reliable performance during subsequent procedures.

• What regulatory clearance does the Stellartech Coagulation System hold?

  The device holds FDA 510(k) clearance under the Special Review pathway for General, Plastic Surgery applications, with clearance number K041383. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for coagulation systems used in endoscopic procedures.

• How should the Stellartech Coagulation System be stored?

  The device must be stored according to the manufacturer’s guidelines to preserve its functionality and sterility. Since it is reusable, storage conditions should prevent contamination and damage, ensuring it remains ready for sterilization and use in clinical settings when needed.