Who is the manufacturer of CERAMIC BLADE ELECTRODE?

Utah Medical Products, Inc. filed the 510(k) submission for CERAMIC BLADE ELECTRODE (K960255).

What is the FDA product code for CERAMIC BLADE ELECTRODE?

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 CERAMIC BLADE ELECTRODE?

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

What are the predicate devices for CERAMIC BLADE ELECTRODE?

UMP DLP-L11 Loop Electrode (K905263); Mega Dyne E-Z Clean Blade (K913473); Aspen Labs Blade Electrode #60-0180-001 (K780977).

Who can help prepare an FDA 510(k) submission like CERAMIC BLADE ELECTRODE?

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.

CERAMIC BLADE ELECTRODE

K960255 · Utah Medical Products, Inc. · GEI · Mar 27, 1996 · General, Plastic Surgery

Device Facts

Record ID	K960255
Device Name	CERAMIC BLADE ELECTRODE
Applicant	Utah Medical Products, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Mar 27, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Utah Medical Products, Inc. (UMP) Ceramic Blade Electrodes (CBE) are intended for use in virtually every surgical discipline where flat, paddle-type electrosurgical blades are used for making straight cuts through tissue. The CBE-2XX blades are intended for use in procedures that require precise cuts where only light or no hemostasis is desired. The CBE-1XX blades are intended for use in procedures where a greater level of hemostasis is desired. When an electrosurgical generator blend mode is used for cutting with the CBE-1XX blades, cauterization of the wound will occur while the cut is being made.

Device Story

Ceramic blade electrode; paddle-type electrosurgical accessory. Input: electrical energy from standard electrosurgical generator via electrosurgical pen. Operation: blade conducts energy to tissue to perform cutting and cauterization. Output: physical tissue incision and wound cauterization. Used in surgical settings by clinicians. Benefits: precise cutting; controlled hemostasis; minimizes bleeding.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Ceramic blade electrode; paddle-type form factor. Compatible with standard electrosurgical pens and generators. Sterilization via gamma radiation. Materials selected for biocompatibility, electrical/thermal properties, and strength.

Indications for Use

Indicated for surgical procedures requiring straight tissue cuts and varying levels of hemostasis, ranging from light/no hemostasis (CBE-2XX) to greater hemostasis (CBE-1XX) via electrosurgical generator blend modes.

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.

Predicate Devices

UMP DLP-L11 Loop Electrode (K905263)
Mega Dyne E-Z Clean Blade (K913473)
Aspen Labs Blade Electrode #60-0180-001 (K780977)

Related Devices

K100258 — ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200 · Wickimed Supply Limited · Apr 28, 2010
K232460 — Disposable electrosurgical pencil (MD1000) · Shenzhen Mecun Medical Supply Co., Ltd. · Oct 11, 2023
K170369 — Disposable Electrosurgical Pencils · Cathay Manfacturing Corp. · Jul 19, 2018
K974735 — STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE · Aaron Medical Industries · Jun 24, 1998
K221815 — Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) · Baisheng Medical Co., Ltd. · Nov 23, 2022

Submission Summary (Full Text)

{0} UTAH MEDICAL PRODUCTS INC. K 960255 SMDA 510(k) Summary MAR 27 1996 Trade Name: Ceramic Blade Electrode Common Name: Electrosurgical Blade Classification: Electrosurgical Cutting and Coagulation Device and Accessories, 21 CFR 878.4400. The Utah Medical Products, Inc. (UMP) Ceramic Blade Electrodes (CBE) are intended for use in virtually every surgical discipline where flat, paddle-type electrosurgical blades are used for making straight cuts through tissue. The CBE-2XX blades are intended for use in procedures that require precise cuts where only light or no hemostasis is desired. The CBE-1XX blades are intended for use in procedures where a greater level of hemostasis is desired. When an electrosurgical generator blend mode is used for cutting with the CBE-1XX blades, cauterization of the wound will occur while the cut is being made. The CBE device is substantially equivalent to the UMP DLP-L11 Loop Electrode (K905263), the Mega Dyne E-Z Clean Blade (K913473), and the Aspen Labs Blade Electrode #60-0180-001 (K780977). The posterior end of the CBE device fits snugly into a standard electrosurgical pen which is connected to an FDA-approved electrosurgical generator. The CBE is used in exactly the same way as the Aspen stainless steel blade and Mega Dyne Teflon®-coated blade electrodes are used for cutting tissues and cauterizing the wound to minimize bleeding. The cutting and cauterization takes place in exactly the same way as with the UMP DLP-L11 Loop Electrode. Materials that comprise the CBE were selected based on properties of strength, biocompatibility, compatibility with gamma sterilization, conformance with commonly used medical grade plastics and other materials, electrical and thermal properties, ease of processing and low cost. Biocompatibility and sterilization information is available from UMP upon request. Kevin L. Cornwell President & CEO -37- UTAH MEDICAL PRODUCTS, INC • 7043 South 300 West • Midvale, Utah 84047-1048 • 801/566-1200 • FAX#801/566-2062