Miltex Rigid Container Systems
by Miltex, Inc.
510(k) K072563
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072563 | Date12 Feb 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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, 19 Sep 2026
The Miltex Rigid Sterilization Container System is a reusable container assembly designed for housing surgical instruments and other medical devices during sterilization processes. Constructed from aluminum alloy, stainless steel, and silicone, it provides a sealed environment to protect contents from contamination while undergoing ethylene oxide (EO) sterilization. The system includes perforated and non-perforated bottoms, lids, and baskets to accommodate various instrument sizes and configurations. Its rigid design ensures structural integrity during sterilization cycles and handling.
This system is intended for use in hospital and healthcare facility sterile processing departments, where it is operated by sterile processing staff. The containers are reusable and require proper cleaning and maintenance between sterilization cycles. The system is approved under FDA 510(k) clearance (K072563) and is designed for ethylene oxide sterilization, with filter-based lids and bottoms to facilitate gas penetration. Storage and handling follow standard sterile processing protocols to maintain sterility and functionality.