Nasal Pancreatic Drainage Set
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171623 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 Nasal Pancreatic Drainage Set is a device classified under the product code FGE and regulation number 876.5010, falling within the medical specialties of Gastroenterology and Urology. It is a stent, drain, or dilator intended for use in the biliary ducts, as indicated by its device name and classification in the openFDA data.
The device received FDA 510(k) clearance (K171623) on July 31, 2017, following a traditional review process, and was found substantially equivalent to a predicate device. It is manufactured by Cook Ireland, Ltd., located at O'Halloran Rd., National Technology Park, Limerick, Ireland, and is authorized for distribution in the United States under FDA regulation.
Frequently asked questions
What is the Nasal Pancreatic Drainage Set used for?
The Nasal Pancreatic Drainage Set is intended for use in the biliary ducts as a stent, drain, or dilator, based on its classification under product code FGE and regulation number 876.5010 in the specialties of Gastroenterology and Urology.
How is the Nasal Pancreatic Drainage Set supplied and is it sterile or single-use?
The device data does not specify sterility, single-use status, or supply format; therefore, no details about how it is supplied, whether it is sterile, or if it is single-use or reusable can be derived from the provided information.
What sizes or models are available for the Nasal Pancreatic Drainage Set?
The device data does not include any specifications regarding sizes, models, or reference numbers for the Nasal Pancreatic Drainage Set, so no details about available sizes or models can be provided.
What is the regulatory status of the Nasal Pancreatic Drainage Set?
The Nasal Pancreatic Drainage Set received FDA 510(k) clearance (K171623) on July 31, 2017, following a traditional review process, and was found substantially equivalent to a predicate device.
Who manufactures the Nasal Pancreatic Drainage Set and where is it authorized for distribution?
The Nasal Pancreatic Drainage Set is manufactured by Cook Ireland, Ltd., located at O'Halloran Rd., National Technology Park, Limerick, Ireland, and is authorized for distribution in the United States under FDA regulation.
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: Nasal Pancreatic Drainage Set (K171623) — FDA 510(k) | Innolitics, K171623 FDA 510 (k) - Nasal Pancreatic Drainage Set, PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ..., Cook G21466 Nasal Pancreatic Drainage Set GUDID Device - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171623 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook Ireland, Ltd.
Sources (1)
- FDA 510(k) K171623 24 fields · synced Sep 24, 2026