Who is the manufacturer of AESCULAP MODULAR MONOPOLAR ELECTRODES?

Aesculap, Inc. filed the 510(k) submission for AESCULAP MODULAR MONOPOLAR ELECTRODES (K970541).

What is the FDA product code for AESCULAP MODULAR MONOPOLAR ELECTRODES?

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 AESCULAP MODULAR MONOPOLAR ELECTRODES?

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

Who can help prepare an FDA 510(k) submission like AESCULAP MODULAR MONOPOLAR ELECTRODES?

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.

AESCULAP MODULAR MONOPOLAR ELECTRODES

K970541 · Aesculap, Inc. · GEI · Mar 28, 1997 · General, Plastic Surgery

Device Facts

Record ID	K970541
Device Name	AESCULAP MODULAR MONOPOLAR ELECTRODES
Applicant	Aesculap, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Mar 28, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Modular Monopolar Electrodes presented in this submission are intended for use in endoscopic surgery (laparoscopy, thoracoscopy) for coagulation and dissection of selected tissue.

Device Story

Modular monopolar electrodes for endoscopic surgery (laparoscopy, thoracoscopy); used for tissue coagulation and dissection. Device consists of three reusable, modular components: insulated handle, insulated shaft, and interchangeable working tips (e.g., J-hook). Operated by surgeons in clinical settings. Device connects to electrosurgical generators (not included) to deliver energy to tissue via the tip. Modular design allows disassembly for cleaning and steam sterilization. Benefits include surgical versatility through interchangeable tips and improved maintenance via modularity.

Clinical Evidence

Bench testing only; no clinical data provided. Compliance with IEC 601-2-18 (safety of endoscopic equipment) and manufacturing per ISO/German DIN standards.

Technological Characteristics

Modular design; 5 mm diameter, 450 mm length. Components: insulated handle (GK382R), insulated shaft (GK380R), and interchangeable working tips. Materials: unspecified insulation materials. Energy: monopolar electrosurgical. Connectivity: none. Sterilization: steam. Standards: IEC 601-2-18, ISO 9001, German DIN.

Indications for Use

Indicated for patients undergoing endoscopic surgery, including laparoscopy and thoracoscopy, requiring coagulation and dissection of tissue.

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.

Related Devices

K171523 — Monopolar Single Use Laparoscopic Instrument · Getsch+Hiller Medizintechnik GmbH · Aug 22, 2017
K102921 — ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES · Bema-GmbH & Co. KG · Dec 20, 2011
K210569 — Disposable Monopolar Laparoscopic Shafts and Reusable Handles · Dannik, LLC · Aug 16, 2021
K081431 — MEG LAPAROSCOPIC ELECTRODES · Bovie Medical · Jul 24, 2008
K982287 — ASLAN SENSOR MODULAR INSTRUMENT · Aslan Medical Technologies, Ltd. · Aug 6, 1998

Submission Summary (Full Text)

{0} AESCULAP MAR 28 1997 K 970541 510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990 Aesculap Modular Monopolar Electrodes February 11, 1997 Submitted by: Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Mary Ellen Holden Phone: (415) 876-7000 x348 FAX: (415) 589-3007 Product: Aesculap Modular Monopolar Electrodes Common Name: Monopolar Electrodes ## Intended Use The Modular Monopolar Electrodes presented in this submission are intended for use in endoscopic surgery (laparoscopy, thoracoscopy) for coagulation and dissection of selected tissue. ## Technological Characteristics Aesculap currently markets a line of non-modular endoscopic monopolar electrodes and a line of modular endoscopic monopolar scissors and forceps which are subject to 510(k) clearance. This submission represents the following design changes: - Change electrodes from a non-modular design to a modular design. - Change in tip insulation material. - Change in shaft insulation material. The Modular Monopolar Electrodes are made up of 3 separate components: an insulated handle (GK382R), an insulated shaft (GK380R) and a working tip. The working tips come in several different styles (i.e. J-shaped hook electrode GK383R) which can be used interchangeably. All components are reusable and disassemble for cleaning and sterilization. The assembled electrodes are 5 mm in diameter and 450 mm in length. They have no suction/irrigation feature. 1000 GATEWAY BOULEVARD • SOUTH SAN FRANCISCO, CA 94080-7030 • USA • 415-876-7000 • FAX: 415-876-7028 {1} 005 ## Performance Standards No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap’s Modular Monopolar Electrodes comply with the requirements of IEC 601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment.) The Modular Monopolar Electrodes will be manufactured in accordance with ISO and German Din Standards. Furthermore, Aesculap AG has received ISO 9001 certification. ## Sterilization The Modular Monopolar Electrodes are provided non-sterile and must be sterilized prior to use. The devices may be sterilized by steam sterilization. ## Substantial Equivalence Aesculap’s Modular Monopolar Electrodes shares similar features and function with corresponding devices distributed by Aesculap, Brimfield and Marlow.