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Repak Surgical Pack (Gown, Towel, Major, Drape, Basic)

by Repack Surgical Enterprises, Inc.

510(k) K880942

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 NumberK880942 Date21 Mar 1988ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

This device is a Sterile Surgical Pack (Product Code: LRO) designed to provide barrier protection during surgical procedures. It includes a major surgical gown, towels, and basic drapes, intended to maintain a sterile field and reduce contamination risk in operating rooms.

The Repak Surgical Pack is supplied as a single-use, sterile barrier system and is regulated under FDA 510(k) clearance (K880942). It is intended for use in surgical settings and must be stored in a clean, dry environment prior to use. No MRI safety or reusable specifications are indicated in the regulatory submission.

Other devices from Repack Surgical Enterprises, Inc.

Questions

AI-generated answers, 19 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 types of surgical procedures is the Repak Surgical Pack designed to protect against contamination during?

    The Repak Surgical Pack is a sterile barrier system intended to maintain a sterile field during surgical procedures by providing protection against contamination. It includes a major surgical gown, towels, and basic drapes, making it suitable for general surgical settings where maintaining sterility is critical, such as in operating rooms for procedures like plastic surgery or other invasive surgeries.

  • Is the Repak Surgical Pack reusable, or is it meant for single-use only?

    The Repak Surgical Pack is explicitly designed for single-use only. This ensures that each pack remains sterile and uncontaminated for one surgical procedure, reducing the risk of cross-contamination between patients.

  • How should the Repak Surgical Pack be stored before use to maintain its sterility?

    The Repak Surgical Pack must be stored in a clean, dry environment prior to use. Proper storage conditions help preserve its sterility and prevent damage to the barrier materials, ensuring it remains effective when needed for surgical procedures.

  • What regulatory pathway was followed for the FDA clearance of the Repak Surgical Pack?

    The Repak Surgical Pack received FDA clearance through a 510(k) submission, specifically under the Traditional clearance type. It was determined to be Substantially Equivalent to a legally marketed device and was reviewed by the General Plastic Surgery advisory committee (SU). The clearance number is K880942.

  • What components are included in the Repak Surgical Pack, and how does this setup benefit surgical teams?

    The Repak Surgical Pack contains a major surgical gown, towels, and basic drapes, all designed to create a comprehensive sterile barrier during surgery. This setup helps surgical teams maintain an uncontaminated field, reducing the risk of infection and improving procedural efficiency by providing all necessary protective layers in one package.