Assure Self-Sealing Sterilization Pouch
510(k) K951590
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK951590 | Date17 May 1995 | 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- Withdrawn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, 1 Oct 2026
The Assure Self-Sealing Sterilization Pouch is a sterile barrier device designed for packaging medical instruments and devices prior to sterilization. It provides a sealed environment to protect contents from contamination during the sterilization process and subsequent storage, ensuring sterility until use. Constructed with self-sealing properties, it eliminates the need for additional sealing mechanisms, reducing the risk of improper closure. The pouch is intended for use in general hospital settings, adhering to standard sterilization protocols.
This pouch is supplied as a single-use item, intended for one-time use after sterilization. It is not reusable and must be discarded after use to maintain sterility. The device is FDA-cleared under the 510(k) pathway (K951590) as substantially equivalent to a predicate device, with no third-party certification required. Storage should follow manufacturer guidelines to preserve integrity, and it is classified under product code KCT for sterilization pouches. No MRI safety or special handling instructions are specified.
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Questions
AI-generated answers, 1 Oct 2026
What is the Assure Self-Sealing Sterilization Pouch used for?
The Assure Self-Sealing Sterilization Pouch is designed as a sterile barrier device for packaging medical instruments and devices before sterilization. It creates a sealed environment to prevent contamination during sterilization and storage, ensuring contents remain sterile until use. This is particularly useful in general hospital settings where maintaining sterility is critical.
Is the Assure Self-Sealing Sterilization Pouch reusable or single-use?
The Assure Self-Sealing Sterilization Pouch is intended for single-use only. After sterilization, it must be discarded to maintain sterility and prevent cross-contamination. The self-sealing feature ensures a secure closure without additional sealing mechanisms, but reuse is not recommended or supported by the manufacturer.
How should the Assure Self-Sealing Sterilization Pouch be stored?
Storage instructions are provided by the manufacturer to preserve the pouch’s integrity. While specific guidelines aren’t detailed in the data, standard practices for sterilization pouches—such as keeping them in a clean, dry environment away from direct sunlight or extreme temperatures—should be followed. Always refer to the manufacturer’s instructions for optimal storage conditions.
Does the Assure Self-Sealing Sterilization Pouch require third-party certification?
No, the Assure Self-Sealing Sterilization Pouch does not require third-party certification. It is FDA-cleared under the 510(k) pathway (K951590), with a determination of substantially equivalent to a predicate device. The clearance was granted through the traditional review process without additional third-party validation.
Are there any special handling instructions for this sterilization pouch?
No special handling instructions (such as MRI safety precautions) are specified for the Assure Self-Sealing Sterilization Pouch. However, standard sterilization protocols should be followed during use, including proper loading of instruments and adherence to manufacturer guidelines for sealing and storage. Always ensure the pouch remains intact to maintain sterility.