CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)

K961061 · Codi International BV · EFQ · Jun 6, 1996 · SU

Device Facts

• Record ID: K961061
• Device Name: CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)
• Applicant: Codi International BV
• Product Code: EFQ · SU
• Decision Date: Jun 6, 1996
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Indications for Use

It is intended that the CODI products will be used as a dressing and for other general medical and dental purposes for which cotton gauze has traditionally been used.

Device Story

Nonwoven synthetic sponge; rayon and polyester fibers; used as dressing for general medical and dental purposes; replaces traditional cotton gauze; provides increased softness, higher absorbency, minimal linting, and reduced wound adhesion; available in sterile and non-sterile versions; intended for use by clinicians in medical and dental settings.

Clinical Evidence

Bench testing only; no clinical data provided. Comparison based on material properties and intended use equivalence to established predicate devices.

Technological Characteristics

Nonwoven synthetic sponge; composition: rayon and polyester fibers; pattern mimics traditional cotton gauze; sterilization: radiation or ethylene oxide.

Indications for Use

Indicated for use as a dressing and for general medical and dental purposes where cotton gauze is traditionally used; applicable to all patient populations requiring wound dressing or general medical/dental absorbent applications.

Predicate Devices

• Nu Gauze (Johnson & Johnson Medical, Inc.)
• Versalon (Kendall Co.)

Submission Summary (Full Text)

{0}

510K SUMMARY
K 961061
JUN - 6 1996

CODI International BV
Turbinestraat 13-19
3903 LV VEENENDAAL
The Netherlands

Telephone: [phone]
Facsimile: 00 31 318 521187

Contact person: Mr. C. van Zwetselaar, Manager of Quality Assurance

March 01, 1996

Trade name of Device: None (to be produced for multiple private labels)
Common Name: General Use Sponge (Non-Sterile and Sterile)
Classification Name: Synthetic Sponge (Non-Sterile and Sterile) (21 CFR 878.4060)

The products to be manufactured by CODI International BV are non-sterile and sterile versions of a nonwoven synthetic sponge that is substantially equivalent to the product currently marketed by Johnson & Johnson Medical, Inc. and known as Nu Gauze and the product currently marketed by Kendall Co. and known as Versalon. The CODI products do not have a different intended use or different technological characteristics than Johnson & Johnson’s Nu Gauze or Kendall’s Versalon. The CODI products are made of rayon and polyester fibers and will be sterilized by radiation or ethylene oxide methods. The finished products have a pattern similar to traditional cotton gauze, but they are softer and more absorbent. The CODI products also have minimal linting and wound adhesion compared to traditional cotton gauze. It is intended that the CODI products will be used as a dressing and for other general medical and dental purposes for which cotton gauze has traditionally been used.

5