← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K014260

# TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE (K014260)

_Tissuelink Medical, Inc. · GEI · Mar 27, 2002 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K014260

## Device Facts

- **Applicant:** Tissuelink Medical, Inc.
- **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md)
- **Decision Date:** Mar 27, 2002
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

The TissueLink Solid Cylinder monopolar device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for blunt dissection, hemostasis of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

## Device Story

The TissueLink Solid Cylinder monopolar device is a sterile, single-use electrosurgical instrument. It functions by delivering radiofrequency (RF) current and saline to soft tissue. The device is used in conjunction with an electrosurgical generator to perform blunt dissection and achieve hemostasis at the operative site. It is designed for use in both endoscopic and open abdominal and thoracic surgical procedures. The device is operated by a surgeon or qualified clinician. By combining RF energy with saline irrigation, the device facilitates tissue dissection and coagulation, potentially reducing blood loss and improving surgical efficiency during procedures.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Monopolar electrosurgical device; solid cylinder tip geometry; utilizes radiofrequency energy and saline irrigation; sterile, single-use; intended for connection to an electrosurgical generator.

## Regulatory 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

- TissueLink Monopolar Floating Ball

## Submission Summary (Full Text)

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510(k) Premarket Submission - TissueLink Medical, Inc. - Solid Cylinder monopolar device

K014260

MAR 2 7 2002

### 510(k) Summary of Safety and Effectiveness

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### Application Information:

| Date Prepared:       | December 21, 2001                                                             |
|----------------------|-------------------------------------------------------------------------------|
| Submitter:           | TissueLink Medical Inc.                                                       |
| Address:             | One Washington Center Suite 400<br>Dover, NH 03820                            |
| Contacts:            | Vicki S. Anastasi<br>Directory Regulatory Affairs                             |
| Telephone Number:    | (508) 922-1622                                                                |
| FAX Number:          | (508) 497-9925                                                                |
|                      | Roberta L. Thompson<br>Vice President, Clinical, Regulatory and Quality       |
| Telephone Number:    | (603) 742-1515 ext. 106                                                       |
| Fax Number:          | (603) 742-1488                                                                |
| Device Information:  |                                                                               |
| Trade Name:          | TissueLink Solid Cylinder monopolar device                                    |
| Common Name:         | Electrosurgery Cauterizing Pen                                                |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories, 21CFR 878.440 |

Claim of Substantial Equivalence of the TissueLink Solid Cylinder monopolar device is made to:

TissueLink Monopolar Floating Ball

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 2 7 2002

Ms. Vicki S. Anastasi Director, Regulatory Affairs TissueLink Medical, Inc. Suite 400 One Washington Center Dover. NH 03820

Re: K014260

Trade/Device Name: TissueLink Solid Cylinder Monopolar Device Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 21, 2001 Received: December 27, 2001

Dear Ms. Anastasi:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use Stated in the enorosale) to tegans and the Medical Device Amendments, or to connineres prior to May 20, 1976, the excordance with the provisions of the Federal Food. Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, dicierole, thanker the act include requirements for annual registration, listing of general volurola provisions practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olassinod (600 as 10) of the major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that i Dri brounder over device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I oderall the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Fee orequirements) ; good manufacturing practice requirements as set CI It Fart 6077, adoling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Vicki S. Anastasi

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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

Enclosure

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510(k) Premarket Submission – TissueLink Medical, Inc. – Solid Cylinder monopolar device

#### Indications for use Statement

Page of of

< 014260 510(k) Number (if known):__

Device Name:

TissueLink Solid Cylinder monopolar device

Indications for Use:

The TissueLink Solid Cylinder monopolar device is a sterile, single use electrosurgery device intended to be used in conjunction with an I like insurgical generator for delivery of radio is current and saline for blunt dissection, hemostation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use Optional Format 1-

(Per 21 CFR 801.109)

muni

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_Ko14260

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K014260](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K014260)

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