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Polyvac Instrument Delivery System

by Symmetry Medical USA, Inc.

510(k) K040223

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 NumberK040223 Date22 Oct 2004ClearedStatusActive

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  • Withdrawn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
KCT
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Polyvac Instrument Delivery System consists of perforated trays with lids designed to enclose and protect medical device instrumentation. The system facilitates the sterilization process by allowing for effective sterilant penetration and air removal.

These trays are intended to house surgical instruments during steam sterilization and maintain the sterility of contents when used with approved sterilization wrap. The system is constructed from perforated plastic or metal components.

Questions

AI-generated answers, 6 Oct 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 primary purpose of the Polyvac Instrument Delivery System?

    The Polyvac Instrument Delivery System is designed to house and protect surgical instruments during the steam sterilization process. Its perforated design allows for effective sterilant penetration and air removal to ensure the instruments are properly processed.

  • How does the system maintain the sterility of surgical instruments?

    The system is constructed from perforated plastic or metal components. These trays are designed to be used in conjunction with approved sterilization wrap to maintain the sterility of the enclosed contents after the sterilization cycle is complete.

  • What is the regulatory status of the Polyvac Instrument Delivery System?

    The Polyvac Instrument Delivery System was cleared via the FDA 510(k) process under K-number K040223. This indicates that the device was found to be substantially equivalent to legally marketed predicate devices.