SURGICAL CUTTER

K955168 · Promex, Inc. · GEI · Jan 22, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K955168
• Device Name: SURGICAL CUTTER
• Applicant: Promex, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

The Surgical Cutter is an electrosurgical device used for cutting and coagulation of tissue. It operates by delivering electrical energy to the surgical site to achieve hemostasis or tissue separation. Used in clinical or surgical settings by physicians or trained surgical staff. The device functions as an accessory to electrosurgical units, providing the physical interface for energy delivery to the patient. It assists in surgical procedures by managing bleeding and facilitating tissue dissection.

Technological Characteristics

Electrosurgical cutting and coagulation device. Classified under 21 CFR 878.4400, product code GEI. Operates via electrical energy delivery for tissue interaction.

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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HUMAN SERVICES CITY
DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center – WO66-G609
Silver Spring, MD 20993-0002

March 7, 2016

Promex, Inc.
Mr. Joseph L. Mark
Vice President
1125 Brookside Ave.
Suite G500
Indianapolis, IN 46202

Re: K955168
Trade/Device Name: Surgical Cutter
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories
Regulatory Class: Class II
Product Code: GEI
Dated: October 26, 1995
Received: November 13, 1995

Dear Mr. Mark:

This letter corrects our substantially equivalent letter of February 17, 2016.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21

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Page 2 – Mr. Joseph Mark

CFR Part 807); labeling (21 CFR 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson
-A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director
Division of Surgical Devices
Office of Device Evaluation
Center for Devices and
Radiological Health