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Pre Op Sponge

by Davis & Geck, Inc.

PMA N17433

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA N17433

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberN17433 Date12 Oct 1978ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

PMA Number
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 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 Pre Op Sponge is a surgical absorbent pad designed for use in preoperative skin preparation and wound management. It is classified under general and plastic surgery supplies, intended for absorbing fluids and maintaining a sterile field during surgical procedures.

This device is supplied as a single-use item and has been authorized under FDA PMA (Premarket Approval) with PMA number N17433. It is intended for use in controlled surgical environments and adheres to regulatory standards for sterile medical devices. No additional specifications regarding MRI safety, sizing, or storage conditions are provided in the available data.

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Questions

AI-generated answers, 18 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 Pre Op Sponge primarily used for in surgical settings?

    The Pre Op Sponge is designed specifically for preoperative skin preparation and wound management. Its absorbent properties help soak up fluids during surgery while maintaining a sterile field, ensuring a cleaner workspace for surgical procedures in controlled environments.

  • Is the Pre Op Sponge intended for reuse, or is it meant to be used only once?

    The Pre Op Sponge is explicitly supplied as a single-use item. This design ensures sterility and hygiene, as reuse could compromise the sterile field and increase infection risks during surgical procedures.

  • How was the Pre Op Sponge’s regulatory approval process handled by the FDA?

    The Pre Op Sponge received FDA authorization through the Premarket Approval (PMA) pathway, indicated by PMA number N17433. This process is typically used for higher-risk medical devices to ensure safety and effectiveness before market release.

  • What type of surgical procedures is the Pre Op Sponge intended for, based on its classification?

    The Pre Op Sponge falls under the category of general and plastic surgery supplies, as noted in its advisory committee classification. While it’s not tied to a specific procedure, its use is intended for controlled surgical environments where maintaining a sterile field is critical.