Uresil Specimen Retrieval Bag
FDA 510(k)Class II (US FDA 510(k))
by Uresil Corp.
Identifiers
- 510(k) Number
- K923219 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Uresil Specimen Retrieval Bag is a medical device used for specimen retrieval in gastroenterology and urology procedures. It is designed to facilitate the collection and containment of specimens during medical examinations.
The device is supplied as a single-use product and is regulated under FDA 510(k) clearance with product code GCJ. It is available in various sizes and is intended for use in clinical settings where specimen retrieval is required.
Frequently asked questions
What is the Uresil Specimen Retrieval Bag used for?
The Uresil Specimen Retrieval Bag is a medical device designed for specimen retrieval in gastroenterology and urology procedures. It facilitates the collection and containment of specimens during medical examinations in clinical settings.
Is the Uresil Specimen Retrieval Bag reusable or single-use?
The Uresil Specimen Retrieval Bag is supplied as a single-use product. It is not intended for reuse and should be discarded after a single procedure to maintain sterility and prevent cross-contamination.
What sizes are available for the Uresil Specimen Retrieval Bag?
The Uresil Specimen Retrieval Bag is available in various sizes to accommodate different specimen retrieval needs during gastroenterology and urology procedures. The specific size options should be selected based on clinical requirements.
What is the regulatory status of the Uresil Specimen Retrieval Bag?
The Uresil Specimen Retrieval Bag is regulated under FDA 510(k) clearance with product code GCJ. It received FDA clearance on December 15, 1992, with the decision code SESE, indicating it is substantially equivalent to predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Uresil Specimen Retrieval Bag - Beudamed, Uresil Corporation - Med on the Go, Uresil Corporation USLTC600 TRU-Close 600 ml Gravity Drainage Bag - Amazon
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K923219 | Class II | Active |
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Manufacturer
- Manufacturer
- Uresil Corp.
Sources (1)
- FDA 510(k) K923219 24 fields · synced Sep 25, 2026