Bard Conformexx Biliary Stent and Delivery System
FDA 510(k) K021994 · C.R. Bard, Inc.
510(k) numberK021994
Submission
- Device name
- Bard Conformexx Biliary Stent and Delivery System
- Applicant
- C.R. Bard, Inc.
Tempe, AZ, US - Received
- June 18, 2002
- Decision date
- January 2, 2003
- Decision
- Unknown (SESU)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary 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 |
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Questions and answers
When was Bard Conformexx Biliary Stent and Delivery System cleared by the FDA?
Bard Conformexx Biliary Stent and Delivery System (K021994) received a 510(k) decision of Unknown on January 2, 2003, 198 days after the submission was received.
What is the product code of K021994?
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.