Sterile Pan Set
510(k) K842136
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842136 | Date6 Jul 1984 | 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- Withdrawn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
- FRG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Sterile Pan Set is a medical device designed for hospital use. It is a sterile set that includes pans for various medical applications.
This device is supplied sterile and is intended for single-use. It is MRI safe and available in various sizes. The device has FDA 510(k) clearance with product code FRG.
Other devices from Medi-Plast Intl., Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the Sterile Pan Set used for?
The Sterile Pan Set is designed for hospital use and includes pans for various medical applications. It is supplied sterile and intended for single-use procedures.
Is the Sterile Pan Set reusable?
No, the Sterile Pan Set is intended for single-use only. It is supplied sterile and should not be reused to maintain sterility and prevent cross-contamination.
What sizes are available for the Sterile Pan Set?
The Sterile Pan Set is available in various sizes to accommodate different medical applications. Specific size options should be confirmed with the manufacturer.
Is the Sterile Pan Set MRI safe?
Yes, the Sterile Pan Set is MRI safe, making it suitable for use in MRI environments where non-MRI compatible devices would pose safety risks.
What regulatory approvals does the Sterile Pan Set have?
The Sterile Pan Set has FDA 510(k) clearance with product code FRG. It was determined to be substantially equivalent to predicate devices through the traditional clearance process.