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Presbyterian Linen Services Surgical Packs

by Medline Industries, Inc.

510(k) K970286

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970286 Date10 Mar 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
LRO
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

Presbyterian Linen Services Surgical Packs are sterile packaging systems designed for use in surgical procedures. These packs contain various medical supplies and instruments needed for surgical operations, organized and presented in a sterile format to maintain aseptic conditions during medical procedures.

The surgical packs are supplied as sterile, single-use devices and are intended for use in general and plastic surgery settings. They are stored according to standard medical supply protocols and have received FDA 510(k) clearance as substantially equivalent devices. The packs are available in various configurations to meet different surgical requirements.

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See all devices from Medline Industries, Inc. →

Questions

AI-generated answers, 27 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 are Presbyterian Linen Services Surgical Packs used for?

    These sterile packaging systems are designed for use in surgical procedures, containing various medical supplies and instruments needed for general and plastic surgery operations. They maintain aseptic conditions during medical procedures.

  • How are the surgical packs supplied and can they be reused?

    The surgical packs are supplied as sterile, single-use devices. They are designed for one-time use only to maintain sterility and should not be reused for subsequent procedures to ensure patient safety.

  • What configurations are available for these surgical packs?

    The packs are available in various configurations to meet different surgical requirements. This allows healthcare providers to select the appropriate set of instruments and supplies based on the specific surgical procedure being performed.

  • What is the regulatory status of these surgical packs?

    The packs have received FDA 510(k) clearance as substantially equivalent devices. This clearance was granted on March 10, 1997, with the K number K970286, indicating they meet the necessary safety and effectiveness requirements for their intended use.