Somnus Medical Tech Malleable Coagulating Electrode

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

510(k) Number

K961133 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Electrosurgical Generator, Model S1

  Class II

  FDA 510(k) K000501 Active Cleared 17 Mar 2000

• Somnus Model 225 Electro Surgical Generator (Model 225)

  Class II

  FDA 510(k) K963772 Active Cleared 23 Oct 1996

• Somnus Model 615 Electrosurgical Generator(Model 615)

  Class II

  FDA 510(k) K970576 Active Cleared 9 Apr 1997

• Somnoplasty System

  Class II

  FDA 510(k) K971450 Active Cleared 17 Jul 1997

• Somnus Disposable Tissue Coagulating Electrode and Somnus Reusable Connector Cable

  Class II

  FDA 510(k) K000720 Active Cleared 30 May 2000

• Somnus Disposable Multiple Electrode Coagulating Probe Model 350

  Class II

  FDA 510(k) K963884 Active Cleared 16 Dec 1996

See all devices from Somnus Medical Technologies, Inc. →

• What is the Somnus Medical Tech Malleable Coagulating Electrode used for?

  This electrode is designed to deliver controlled electrical energy for tissue coagulation during surgical procedures, helping clinicians achieve precise hemostasis and minimize bleeding in soft tissues. Its malleable construction allows it to be shaped to fit specific anatomical contours, making it adaptable for general and plastic surgery applications.

• How is the Somnus Medical Tech Malleable Coagulating Electrode supplied and intended for use?

  The electrode is supplied sterile and packaged for single-use only in sterile surgical environments. It is intended to be used once per procedure and discarded afterward, ensuring compliance with infection control protocols. It requires compatibility with standard electrosurgical units and proper grounding for safe operation.

• Is the Somnus Medical Tech Malleable Coagulating Electrode reusable?

  No, the electrode is explicitly designed for single-use only. Reusing it could compromise sterility and increase the risk of infection or device malfunction, which is why it is packaged and labeled for one-time clinical use.

• What surgical settings is this electrode intended for?

  This electrode is primarily intended for use in general and plastic surgery settings. Its design supports controlled coagulation, making it suitable for procedures where precise hemostasis is critical, such as soft tissue surgeries.

• Does the Somnus Medical Tech Malleable Coagulating Electrode have any special storage requirements?

  While specific storage instructions are not detailed in the regulatory records, as a sterile, single-use device, it should be stored in its original packaging until use. The packaging should be kept dry, protected from physical damage, and away from extreme temperatures to maintain sterility and functionality.