VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010

K982212 · Synergetics, Inc. · GEI · Dec 2, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982212
• Device Name: VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010
• Applicant: Synergetics, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SYNERGETICS VERITAS... Non-Stick Bipolar Forceps is a reusable instrument designed for bipolar coagulation during surgical procedures. It is designed for use with most available bipolar electrosurgical units, and will provide a means of transmitting and applying cauterization to captured tissue and small bleeding vessels, thereby causing coagulation and hemostasis

Device Story

Veritas Bipolar Forceps (Model N301-005) is a reusable surgical instrument for bipolar electrosurgical coagulation. Device connects to standard bipolar electrosurgical units; transmits electrical current to captured tissue or small bleeding vessels to induce hemostasis. Used by surgeons in clinical/OR settings. Provides non-stick cauterization capability. Benefits include controlled tissue coagulation and effective bleeding management during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable bipolar forceps with 0.5mm tip. Insulated construction. Compatible with standard bipolar electrosurgical units. Mechanical design for tissue grasping and electrical transmission.

Indications for Use

Indicated for use in surgical procedures requiring bipolar coagulation of tissue and small bleeding vessels to achieve hemostasis. Intended for prescription use by clinicians.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1998 DEC

Mr. Kurt Gampp Executive Vice President Synergetics, Inc. 88 Hubble Drive St. Charles, Missouri 63304-8694

Re: K982212

Trade Name: Veritas Bipolar, Insulated, O.5MM TIP, Model N301-005 Regulatory Class: II Product Code: GEI Dated: November 10, 1998 Received: November 12, 1998

Dear Mr. Gampp:

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 legally marketed predicate 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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. Kurt Gampp

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/dsma/dsmamain.html".

Sincerely yours,

p coella

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K982212

## INTENDED USE

The SYNERGETICS VERITAS... Non-Stick Bipolar Forceps is a reusable instrument designed for bipolar coagulation during surgical procedures. It is designed for use with most available bipolar electrosurgical units, and will provide a means of transmitting and applying cauterization to captured tissue and small bleeding vessels, thereby causing coagulation and hemostasis

pcooe

(Division Sign-Off) Division of General Restorative I 510(k) Numbe

Prescription Use
(Per 21 CFR 801.109)