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Cotton Neurological Sponge

by American Silk Sutures, Inc.

510(k) K854713

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK854713 Date20 Mar 1986ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1726-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1751-2016 FDA Class II initiated 31 Mar 2016 on shared 510(k) K854713
    • Terminated Z-1725-2016 FDA Class II initiated 31 Mar 2016

    Product packaging defective compromising sterility

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HBA
Device Class
Class II
Regulation
21 CFR Part 882.4700
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cotton Neurological Sponge is a neurosurgical paddle device made of cotton material. It is designed for use in neurological procedures to assist in surgical applications.

This device is supplied as a single-use item and is not MRI safe. It is stored according to standard medical device protocols and has FDA 510(k) clearance with the product code HBA.

Other devices from American Silk Sutures, Inc.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Cotton Neurological Sponge used for?

    The Cotton Neurological Sponge is a neurosurgical paddle device made of cotton material designed for use in neurological procedures to assist in surgical applications.

  • Is the Cotton Neurological Sponge reusable or single-use?

    The Cotton Neurological Sponge is supplied as a single-use item and is not MRI safe. It should be discarded after a single procedure to maintain sterility and safety.

  • What is the regulatory status of the Cotton Neurological Sponge?

    The Cotton Neurological Sponge has FDA 510(k) clearance with the product code HBA. It is classified as a Class 2 device and is substantially equivalent to other neurosurgical paddles.

  • How should the Cotton Neurological Sponge be stored?

    The Cotton Neurological Sponge should be stored according to standard medical device protocols to maintain its integrity and sterility until use.