Identifiers
- 510(k) Number
- K130251 FDA 510(k)
- FDA Product Code
- JAQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5700 FDA 510(k)
- Regulation Number
- 892.5700 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Esophagus Bougie Set is a medical device classified as an applicator designed for use in radiology. It is intended to assist in the precise delivery of a radiation source to the esophagus during brachytherapy procedures, specifically when paired with a high-dose-rate afterloader system.
This device is supplied as a reusable medical instrument and is intended for use in a clinical radiology setting. It includes components such as a bougie tube, catheter, clamping screw, bite protector, and threaded ring. The Esophagus Bougie Set holds an FDA 510(k) clearance under the Radiology advisory committee and is regulated under 21 CFR 892.5700. No sterility or single-use specifications are noted in the provided data.
Frequently asked questions
What is the Esophagus Bougie Set intended for?
The Esophagus Bougie Set is intended to assist in the precise delivery of a radiation source to the esophagus during brachytherapy procedures when used with a high-dose-rate afterloader system, as stated in the device description.
Is the Esophagus Bougie Set reusable or single-use?
The Esophagus Bougie Set is supplied as a reusable medical instrument, as explicitly noted in the description, and is intended for use in a clinical radiology setting.
What components are included in the Esophagus Bougie Set?
The Esophagus Bougie Set includes a bougie tube, catheter, clamping screw, bite protector, and threaded ring, as listed in the device description.
How is the Esophagus Bougie Set regulated?
The Esophagus Bougie Set is regulated under 21 CFR 892.5700 and holds an FDA 510(k) clearance, as indicated in the device data under regulation_number and AUTHORIZATIONS.
Is sterility specified for the Esophagus Bougie Set?
No sterility specifications are noted in the provided device data, so sterility status cannot be confirmed from the information given.
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: Esophagus Bougie Set by Varian Medical Systems, Inc. | FDA 510 (k) Summary, ESOPHAGUS BOUGIE SET (K130251) — FDA 510(k) | Innolitics, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130251 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (1)
- FDA 510(k) K130251 24 fields · synced Sep 19, 2026