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Repak Surgical Packs

by Repack Surgical Enterprises, Inc.

510(k) K903908

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 NumberK903908 Date26 Oct 1990ClearedStatusActive

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  • Withdrawn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
KKX
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.

Repak Surgical Packs are sterile, single-use surgical packs designed for use in general and plastic surgery procedures. These packs are intended to provide a barrier between the sterile field and the environment, reducing the risk of contamination during surgical interventions.

The packs are supplied in a sterile, ready-to-use format and are classified under product code KKX (21 CFR 878.4370). They were granted FDA 510(k) clearance under Traditional review in 1990, with a decision of Substantially Equivalent (SESE) by the Surgical and Urological Devices Panel (SU). No third-party review was involved, and the device is intended for single-use only.

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 type of surgeries are REPAK SURGICAL PACKS intended for?

    The device description states the packs are designed for general and plastic surgery procedures, so they are intended to be used in any operation falling under those specialties. This is derived directly from the listed intended use, not from any regulatory claim.

  • Are the packs supplied sterile and ready for immediate use?

    Yes, the specifications describe the packs as sterile and provided in a ready‑to‑use format. This means they arrive pre‑sterilized and can be opened directly in the operating room without additional processing, as indicated in the product description.

  • Can the REPAK SURGICAL PACKS be reused after a procedure?

    The data explicitly notes the device is intended for single‑use only. Therefore, after one surgical case the pack must be discarded and not reprocessed or reused, consistent with the single‑use designation in the description.

  • How is the regulatory clearance of the packs described?

    The device received FDA 510(k) clearance via a Traditional review in 1990, with a decision of Substantially Equivalent (SESE) by the Surgical and Urological Devices Panel. This information is taken verbatim from the authorizations and decision fields, confirming its cleared status without adding any other regulatory language.