Who is the manufacturer of UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH?

Unimed Surgical Products, Inc. filed the 510(k) submission for UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH (K963338).

What is the FDA product code for UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Related Devices

K102275 — THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240 · Thermedx, LLC · Mar 25, 2011
K091290 — ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 · Ethicon Endo-Surgery, Inc. · Oct 29, 2009
K142410 — Elliquence Electrodes · Elliquence, LLC · Oct 30, 2015
K091223 — VALLEYLAB SUCTION COAGULATOR, MODEL E3305 · Covidien LP · Sep 11, 2009
K180031 — Endopath Electrosurgery Probe Plus II · Ethicon Endo-Surgery, LLC · May 7, 2018

Submission Summary (Full Text)

{0} 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.