AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES

K962807 · American Surgical Sponges · HBA · May 2, 1997 · Neurology

Device Facts

• Record ID: K962807
• Device Name: AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES
• Applicant: American Surgical Sponges
• Product Code: HBA · Neurology
• Decision Date: May 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4700
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is intended to be used by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.

Device Story

Non-adherent, strung, x-ray detectable surgical sponge; sterile, disposable. Used by physicians during neurosurgical procedures; protects neural tissues from drying, abrasion, or contamination; absorbs fluids.

Clinical Evidence

Bench testing only; no clinical data.

Technological Characteristics

Non-adherent, strung, x-ray detectable surgical sponge; sterile, disposable; cottonoid material.

Indications for Use

Indicated for use by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.

Regulatory Classification

Identification

A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

Predicate Devices

• Telfa Non-Adherent neurological sponge (K904515)

Submission Summary (Full Text)

{0}

American Surgical Sponges
Div. of American Silk Sutures, Inc.
K962807
DEVELOPERS OF TAKA'S™, COL-R-SPONGE™, AMERICOT™, RAY-COT™ & UNIQCOT™ SPONGES

MAY - 2 1997

ATTACHMENT #1
510(K) SUMMARY
Page 1 of 2

## 510(k) SUMMARY
## AMERICAN SURGICAL SPONGE
## NEUROLOGICAL SPONGE

### Submitter Information:
American Surgical Sponges, a Division of American Silk Sutures
82 Sanderson Avenue
Lynn, MA 01921

## 510(k) Summary Prepared By:
Carolann Kotula
mdi Consultants, Inc.
55 Northern Boulevard
Great Neck, NY 11021
Telephone Number: [phone]

Date 510(k) Summary Prepared: July 12, 1996

### Name of the Device:
Trade or Proprietary Name: American Surgical Sponges (brand)
Neurological Sponges

Common Name: Neurosurgical paddle or sponge

Classification Name: Cottonoid Paddle (21 CFR 882.4700)

### Identification of Legally Marketed device to which the Submitter claims equivalence:
This device is substantially equivalent to a Telfa Non-Adherent neurological sponge marketed by American Surgical Sponges, a Division of American Silk Sutures under K904515.

82 Sanderson Avenue, Lynn, MA 01902
Phone: [phone] • Fax: [phone]

{1}

ATTACHMENT #1
510(K) SUMMARY
Page 2 of 2

## Description of the Subject Devices:

The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable.

## Intended Use:

This device is intended to be used by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.

## Technological Characteristics of the Subject Device:

Performance evaluations (comparisons with the predicate) were not conducted as there are no significant technological differences between the devices.