Who is the manufacturer of ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE?

ETHICON, Inc. filed the 510(k) submission for ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE (K960476).

What is the FDA product code for ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE?

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 ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE?

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

Who can help prepare an FDA 510(k) submission like ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE?

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.

ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE

Q: What are the predicate devices for ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE?

EVERSHEARS II Bipolar Laparoscopic Scissors.

K960476 · ETHICON, Inc. · GEI · Apr 5, 1996 · General, Plastic Surgery

Device Facts

Record ID	K960476
Device Name	ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE
Applicant	ETHICON, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Apr 5, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The intended use of the ETHICON Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures.

Device Story

ETHICON Bipolar Scissors; reusable surgical instrument; connects to electrosurgical generator via ETHICON Bipolar Cable; facilitates dissection, transection, and bipolar coagulation of soft tissue; used in open surgical procedures by surgeons; provides mechanical cutting and electrical coagulation; benefits include combined cutting/coagulation functionality in single device.

Clinical Evidence

Bench testing only. Preclinical laboratory and benchtop evaluations performed in compliance with ANSI/AAMI HF-18. No clinical data provided.

Technological Characteristics

Reusable bipolar electrosurgical scissors; connects to electrosurgical generator via accessory cable; designed for open surgery; complies with ANSI/AAMI HF-18 standard.

Indications for Use

Indicated for cutting and bipolar coagulation of soft tissue in open surgical procedures using non-sterile, reusable devices.

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

EVERSHEARS II Bipolar Laparoscopic Scissors

Related Devices

K981361 — POWERSTAR BIPOLAR SCISSORS · ETHICON, Inc. · Jul 13, 1998
K973173 — POWERSTAR BIPOLAR SCISSORS · ETHICON, Inc. · Oct 29, 1997
K042077 — BITECH BIPOLAR SCISSORS · Guenter Bissinger Medizintechnik GmbH · Oct 27, 2004
K981219 — OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES · Enable Medical Corp. · Jun 29, 1998
K972558 — BIPOLAR SCISSORS · Enable Medical Corp. · Oct 7, 1997

Submission Summary (Full Text)

{0} K960476 # SECTION 7 ## SUMMARY OF SAFETY AND EFFECTIVENESS ### 510(k) Summary of Safety and Effectiveness Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. **NEW DEVICE NAME**: ETHICON Bipolar Scissors and Accessory Cable **PREDICATE DEVICE NAME**: EVERSHEARS II Bipolar Laparoscopic Scissors ### 510(k) SUMMARY ### Device Description The ETHICON Bipolar Scissors are available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation. The ETHICON Bipolar Scissors are designed for use with the ETHICON Bipolar Cable (Accessory). The ETHICON Bipolar Cable is used to connect the ETHICON Bipolar Scissors to the generator (ESU). ### Intended Use The intended use of the ETHICON Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures. Continued on next page ETHICON Bipolar Scissors and Accessory Cable ETHICON, Inc. {1} # SUMMARY OF SAFETY AND EFFECTIVENESS, Continued | Indications Statement | The ETHICON Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures. | | --- | --- | | Technological Characteristics | The new device is technologically the same as the predicate except that the device is not designed for endoscopic procedures. This difference does not raise any new questions of safety and effectiveness. | | Performance Data | Preclinical laboratory and benchtop evaluations (complies with ANSI/AAMI HF-18) were performed to ensure that the device functions as intended. Clinical data was deemed unnecessary to support the Premarket Notification. Sufficient data has been gathered from pre-clinical and benchtop testing to assess the safety and effectiveness characteristics of the new device. | | Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act. | | Contact | John D. Paulson, Ph.D Director, Regulatory Affairs ETHICON, Inc. Rt. #22 West Somerville, NJ 08876-0151 | | Date | January 31, 1996 | ETHICON Bipolar Scissors and Accessory Cable ETHICON, Inc.