Angiodynamics Balloon Expandable Biliary Stent System
FDA 510(k) K991793 · AngioDynamics, Inc.
510(k) numberK991793
Submission
- Device name
- Angiodynamics Balloon Expandable Biliary Stent System
- Applicant
- AngioDynamics, Inc.
Queensburgy, NY, US - Received
- May 26, 1999
- Decision date
- June 25, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
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| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…FGE · Traditional | Olympus Medical Systems Corporation | 10/21/2025SE |
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Questions and answers
When was Angiodynamics Balloon Expandable Biliary Stent System cleared by the FDA?
Angiodynamics Balloon Expandable Biliary Stent System (K991793) received a 510(k) decision of Substantially Equivalent on June 25, 1999, 30 days after the submission was received.
What is the product code of K991793?
The FDA product code is FGE – Stents, Drains And Dilators For The Biliary Ducts, a Class II (moderate risk) device regulated under 21 CFR 876.5010.