Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System
FDA 510(k) K122546 · Idev Technologies, Inc.
510(k) numberK122546
Submission
- Device name
- Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System
- Applicant
- Idev Technologies, Inc.
Webster, TX, US - Received
- August 21, 2012
- Decision date
- December 7, 2012
- Decision
- Unknown (SESU)
- Type
- Traditional 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
Other 510(k)s with product code FGE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260835 | ARCHIMEDES Biodegradable Stent (Medium)FGE · Traditional | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 07/27/2026SE |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018…FGE · Traditional | Hangzhou AGS MedTech Co., Ltd. | 06/24/2026SE |
| K253832 | Dilation Balloon CatheterFGE · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 04/24/2026SE |
| K251658 | Endoflux Biliary & Pancreatic Stent SetsFGE · Traditional | Medi-Globe GmbH | 04/16/2026SE |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235)FGE · Traditional | GIE Medical | 03/13/2026SE |
| K253132 | Single use stone retrieval balloonsFGE · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 03/06/2026SE |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE · Traditional | Taewoong Medical Co., Ltd. | 12/29/2025SESU |
| 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 |
More from Softac Medical Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K130591 | Supera VeritasFGE · Traditional | 05/02/2013SESU |
| K111627 | Supera Veritas(R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemFGE · Traditional | 08/21/2012SESU |
| K111766 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsFGE · Traditional | 10/19/2011SESU |
| K093893 | Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemFGE · Traditional | 10/05/2010SESU |
| K071646 | Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model #…FGE · Traditional | 01/31/2008SESU |
| K060557 | Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery CATHETER-SS06120060FGE · Traditional | 08/15/2006SESU |
| K050926 | Texan Longhorn Foreign Body Retrieval Device, Model TX30120060MMX · Special | 05/09/2005SE |
| K041374 | Akonya Eliminator Mechanical Thrombectomy Device, Model EL10060060QEW · Traditional | 03/02/2005SE |
| K033188 | Texan Foreign Body Retrieval Device, Model TX30060050MMX · Traditional | 11/19/2003SE |
| K030504 | Akonya Eliminator Mechanical Thrombectomy Device, Model El 10060060MCW · Traditional | 09/16/2003SE |
Questions and answers
When was Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System cleared by the FDA?
Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (K122546) received a 510(k) decision of Unknown on December 7, 2012, 108 days after the submission was received.
What is the product code of K122546?
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.