Identifiers
- 510(k) Number
- K210248 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 Lab Bag with Fabric Pouch is a medical device designed for the containment and transport of laboratory specimens or medical instruments. It serves as a protective enclosure to maintain sterility and integrity of contents during handling and transit, particularly in clinical settings such as gastroenterology or urology procedures.
This device is supplied as a single-use item and is classified under FDA product code GCJ. It received FDA 510(k) clearance on July 30, 2021, under the designation K210248, with a determination of substantial equivalence. The bag is intended for use in controlled environments where specimen or instrument protection is required, adhering to regulatory standards for medical transport containers.
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: K210248 - Lab Bag with Fabric Pouch - FDA 510 (k), Lab Bag with Fabric Pouch (K210248) — FDA 510(k) | Innolitics, Lab Bag with Fabric Pouch - FDA 510 (k) K210248 | MedTracker, PDF K210248 - Lab Bag with Fabric Pouch - 510kdatabase.net, K210248 - Lab Bag with Fabric Pouch - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210248 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Medical Design Co., Ltd.
Sources (1)
- FDA 510(k) K210248 24 fields · synced Sep 18, 2026