K961771 · United States Surgical, A Division of Tyco Healthc · GEI · Sep 25, 1996 · General, Plastic Surgery
Device Facts
Record ID
K961771
Device Name
AUTO SUTURE SURGIWAND
Applicant
United States Surgical, A Division of Tyco Healthc
Product Code
GEI · General, Plastic Surgery
Decision Date
Sep 25, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4400
Device Class
Class 2
Indications for Use
The AUTO SUTURE* Suction / Irrigation** device is intended to allow the surgeon to gently blow blood and debris from the surgical site.
Device Story
Hand-held surgical instrument; used in open and thoracoscopic procedures; operated by surgeons. Device functions to suction or irrigate surgical sites; expanded utility allows gentle blowing of blood and debris from site. Design, function, and performance identical to predicate; manufactured using same bio-approved materials and processes as existing USSC surgical accessories.
Clinical Evidence
No clinical data; substantial equivalence based on design, material, and functional comparison to predicate.
Indicated for open and thoracoscopic surgery (non-insufflated) to remove blood and debris from the surgical site.
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.
{0}
SEP 25 1986
K96/771
# SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:
The AUTO SUTURE* Suction / Irrigation** device is identical in safety and effectiveness to its currently marketed predicate - U.S. Surgical Corp.'s *Endoscopic Suction / Irrigation** device - 510(k) #K903207. United States Surgical Corporation has been manufacturing hand instruments as accessories in surgical procedures for a number of years. It is now the intention of USSC to expand the utility of the AUTO SUTURE* Endoscopic Suction / Irrigation** device to allow the surgeon to gently blow blood and debris from the surgical site. The information included in this notification demonstrates that the device is substantially equivalent to its predicate in respect to design, function, performance, labeling and sterilization. *The sole difference between the subject and device and the predicate device, is that the predicate device is indicated for endoscopic surgery while the subject device is only indicated for open and thoracoscopic surgery (non-insufflated).*
- Both the subject and predicate devices are designed and to perform the exact same functions.
- Both the subject devices and other currently marketed United States Surgical Corporation devices are manufactured in the same facilities, using similar processes and controls.
- Both the subject devices and other currently marketed United States Surgical Corporation devices are packaged in the same facilities using similar processes and controls.
- Both the subject and predicate devices perform the exact same function in the same way.
- Both the subject and predicate devices are manufactured from the exact same bio-approved materials
* Trademark of United States Surgical Corporation
** Trademark name not yet determined
