← Product Code [HBA](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA) · K962807

# AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES (K962807)

_American Surgical Sponges · HBA · May 2, 1997 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K962807

## Device Facts

- **Applicant:** American Surgical Sponges
- **Product Code:** [HBA](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA.md)
- **Decision Date:** May 2, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4700
- **Device Class:** Class 2
- **Review Panel:** Neurology
- **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.

## Regulatory 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](/device/K904515.md))

## Submission Summary (Full Text)

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{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: (516) 482-9001

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: (617) 592-7200 • Fax: (617) 595-5460

{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.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K962807](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K962807)

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