UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH

K963338 · Unimed Surgical Products, Inc. · GEI · Oct 21, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K963338
• Device Name: UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH
• Applicant: Unimed Surgical Products, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The unimed Surgical Products unimed Suction-Irrigation Electrode and unimed Sliding Sheath are electrosurgical devices designed for suction/irrigation as well as cutting and coagulating of soft tissue.

Device Story

Electrosurgical device for suction, irrigation, cutting, and coagulation of soft tissue; features five tip configurations (Spatula, J-Hook, L-Hook, Coagulator, Needle); 5mm shaft diameter; 28cm or 32cm working lengths; proximal end connects to standard monopolar cord; used by surgeons in clinical settings; provides simultaneous fluid management and electrosurgical tissue interaction; facilitates surgical site visualization and hemostasis.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Electrosurgical device; non-toxic materials; 5mm shaft diameter; 28cm/32cm lengths; monopolar connectivity; five interchangeable tip configurations (Spatula, J-Hook, L-Hook, Coagulator, Needle).

Indications for Use

Indicated for suction, irrigation, cutting, and coagulation of soft tissue during electrosurgical procedures.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Reference Devices

• Cabot Medical Suction-Irrigation Electrodes
• American Hydro-Surgical Instruments Suction-Irrigation Electrodes

Submission Summary (Full Text)

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K 96 3338

OCT 21 1996

# SAFETY AND EFFECTIVENESS SUMMARY

**COMMON/USUAL NAME:** Electrosurgical Electrodes

**PROPRIETARY NAME:** *unimed* Suction-Irrigation Electrode and *unimed* Sliding Sheath

**CLASSIFICATION:** CLASS II

**MATERIALS:** All materials used to manufacture the *unimed* Suction-Irrigation Electrode and *unimed* Sliding Sheath are non-toxic and have been used in other previously marketed devices.

**DESCRIPTION:** The *unimed* Surgical Products *unimed* Suction-Irrigation Electrode and *unimed* Sliding Sheath are electrosurgical devices designed for suction/irrigation as well as cutting and coagulating of soft tissue.

*unimed* Surgical Products intends to market the *unimed* Suction-Irrigation Electrode with five tip configurations. The tip configurations are the Spatula, J-Hook, L-Hook, Coagulator and Needle. The electrodes are available with a shaft diameter of 5mm and a working length of 28cm or 32 cm. The *unimed* Sliding Sheath will be marketed in one configuration in 28cm and 32cm lengths. The proximal end is designed to fit a standard monopolar cord.

**SUBSTANTIAL EQUIVALENCE:** The *unimed* Suction-Irrigation Electrodes and *unimed* Sliding Sheath are similar to other Suction-Irrigation Electrodes currently commercially available. Numerous electrodes with a variety of tip configurations are marketed by Cabot Medical and American Hydro-Surgical Instruments.