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Jewel Precision Reusable Rigid Sterilization Container System

by Jewel Precision Sheet Metal & Machine, Inc.

510(k) K162600

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK162600 Date9 Dec 2016ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2026-2025 FDA Class II initiated 22 May 2025

    The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.

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  • Withdrawn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