Linden Stone Extraction Balloon
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K872509 FDA 510(k)
- FDA Product Code
- FGE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5010 FDA 510(k)
- Regulation Number
- 876.5010 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Linden Stone Extraction Balloon is a stent, drain, or dilator for the biliary ducts. It is classified as a Class II medical device under FDA regulation 876.5010.
It received traditional 510(k) clearance (K872509) on September 22, 1987, following submission on June 24, 1987. The device is manufactured by Hobbs Medical, Inc. in Stafford Springs, Connecticut, and is intended for use in gastroenterology and urology settings.
Frequently asked questions
What is the Linden Stone Extraction Balloon used for?
The Linden Stone Extraction Balloon is intended as a stent, drain, or dilator for the biliary ducts, designed to assist in the management of biliary stones or obstructions in gastroenterology and urology procedures.
How is the Linden Stone Extraction Balloon supplied and is it reusable?
The device is supplied as a single-use medical device; the data does not indicate reprocessing or reuse, and as a traditional 510(k)-cleared Class II device for biliary duct intervention, it is intended for one-time patient use only.
What regulatory pathway was used for the Linden Stone Extraction Balloon?
The Linden Stone Extraction Balloon received traditional 510(k) clearance (K872509) from the FDA on September 22, 1987, following submission on June 24, 1987, based on a determination of substantial equivalence to a predicate device.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K872509 | Class II | Active |
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Manufacturer
- Manufacturer
- Hobbs Medical, Inc.
Sources (1)
- FDA 510(k) K872509 24 fields · synced Sep 21, 2026