Angiodynamics Angiostent Biliary Stent System
FDA 510(k) K982346 · AngioDynamics, Inc.
510(k) numberK982346
Submission
- Device name
- Angiodynamics Angiostent Biliary Stent System
- Applicant
- AngioDynamics, Inc.
Queensburgy, NY, US - Received
- July 6, 1998
- Decision date
- January 29, 1999
- Decision
- Unknown (SESU)
- Type
- Traditional 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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| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE · Traditional | Bioteque Corporation | 12/22/2025SE |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…FGE · Traditional | Olympus Medical Systems Corporation | 10/21/2025SE |
| K251229 | EndoFixTissue Fixation SystemFGE · Traditional | Softac Medical Technologies | 08/20/2025SE |
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Questions and answers
When was Angiodynamics Angiostent Biliary Stent System cleared by the FDA?
Angiodynamics Angiostent Biliary Stent System (K982346) received a 510(k) decision of Unknown on January 29, 1999, 207 days after the submission was received.
What is the product code of K982346?
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.