CABLE HOLDER, SUCTION TUBE HOLDER

K971040 · Contour Fabricators, Inc. · GEI · Apr 16, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971040
• Device Name: CABLE HOLDER, SUCTION TUBE HOLDER
• Applicant: Contour Fabricators, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The sterile, disposable cable or tube holder is intended to limit the amount of excess cable or tubing that extends into the surgical field. The holders are offered in 1/2" and 3/4" sizes to allow for a variety of diameters. Pressure sensitive adhesive is attached to the back of both sizes to allow for easy attachment to a clean, dry surface.

Device Story

Cable/suction tube holder; nylon construction; 1/2" or 3/4" diameter; pressure-sensitive adhesive backing for surface attachment; flexible lock-and-release loops for cable/tube retention. Used in surgical environments to manage excess tubing/cables, reducing clutter in the surgical field. Device is sterile and disposable.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nylon construction; pressure-sensitive adhesive backing; flexible lock-and-release loop mechanism; 1/2" and 3/4" diameter sizes; sterile, disposable.

Indications for Use

Indicated for use in surgical settings to secure and manage excess cables or tubing, preventing them from extending into the surgical field.

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.

Predicate Devices

• Technadyne Endoscopic Instrument Holder (K940891)

Submission Summary (Full Text)

{0}

510(K) SUMMARY
(as required by 807.92(c))

K971040

Submitter of 510(k):
Contour Fabricators, Inc.
4100 East Baldwin Rd.
Grand Blanc, MI 48439
Phone: [phone]
Fax: [phone]
APR 16 1997

Contact Person: Michael W. Czop
Date of Summary: March 19, 1997
Trade Name: Cable Holder
Suction Tube Holder
Classification Name: n/a
Predicate Device: Tecnadyne Scientific Incorporated,
"Technadyne Endoscopic Instrument Holder"
K940891

Device Description: The cable or suction tube holder is a sturdy nylon construction available in 1/2" or 3/4" diameter. Pressure sensitive adhesive backing allows for the holders to be positioned on a clean, dry surface. Flexible lock and release loops allow the cable or tube to be retained and held in place.

Intended Use: The sterile, disposable cable or tube holder is intended to limit the amount of excess cable or tubing that extends into the surgical field. The holders are offered in 1/2" and 3/4" sizes to allow for a variety of diameters. Pressure sensitive adhesive is attached to the back of both sizes to allow for easy attachment to a clean, dry surface.