TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS

K964176 · Tecno Instruments (Usa), Inc. · GEI · Aug 14, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964176
• Device Name: TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS
• Applicant: Tecno Instruments (Usa), Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Tecno reusable bipolar electrosurgical forceps is to grasp and coagulate (control bleeding) by use of high-frequency electrical current. The forceps can be used multiple times and have been AAMI performance tested after 20 exposures to steam sterilization. The areas of specialty that the Tecno electrosurgical bipolar forceps will be used is: neurosurgical, ophthalmic, plastic and reconstructive surgical procedures.

Device Story

Reusable bipolar electrosurgical forceps; used to grasp tissue and deliver high-frequency electrical current for coagulation/hemostasis. Operated by surgeons in neurosurgical, ophthalmic, and plastic/reconstructive procedures. Device connects to electrosurgical generator; current flows between two tips to heat and coagulate tissue. Reusable design validated for 20 steam sterilization cycles. Benefits include effective bleeding control in delicate surgical fields.

Clinical Evidence

Bench testing only; AAMI performance testing conducted after 20 steam sterilization cycles.

Technological Characteristics

Bipolar electrosurgical forceps; reusable; steam sterilization compatible; AAMI performance tested; high-frequency electrical energy source.

Indications for Use

Indicated for hemorrhaging of compromised tissue requiring coagulation during invasive neurosurgical, ophthalmic, and plastic/reconstructive surgical 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Michael T. Janocik
President
Rightworks, Inc.
PO Box 991251
Louisville, Kentucky 40269

AUG 14 1997

Re: K964176
Trade Name: Reusable Bipolar Electrosurgical Forceps
Regulatory Class: II
Product Code: GEI
Dated: June 18, 1997
Received: June 20, 1997

Dear Mr. Janocik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Michael T. Janocik

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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Page 1 of 1

510(k) Number (if known): K964176

Device Name: REUSABLE BIPOLAR ELECTRO-SURGICAL FORCEPS

Indications For Use:

The intended use of the Tecno reusable bipolar electrosurgical forceps is to grasp and coagulate (control bleeding) by use of high-frequency electrical current. The forceps can be used multiple times and have been AAMI performance tested after 20 exposures to steam sterilization. The areas of specialty that the Tecno electrosurgical bipolar forceps will be used is: neurosurgical, ophthalmic, plastic and reconstructive surgical procedures.

Indications for use are hemorrhaging of compromised tissue and subsequent need to coagulate during invasive surgical procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K964176

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐
(Optional Format 1-2-96)