Porges Biliary Stents
FDA 510(k) K896423 · Porges Corp.
510(k) numberK896423
Submission
- Device name
- Porges Biliary Stents
- Applicant
- Porges Corp.
Gary, IN, US - Received
- November 8, 1989
- Decision date
- January 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K900269 | Porges Dormia 3 FR Flat Wire Basket Stone DislodgeFFL · Traditional | 07/03/1990SE |
| K900031 | Modified Pediatric Silicone Foley CathetersKNY · Traditional | 03/06/1990SE |
| K896505 | Porges Universal HandlesGCP · Traditional | 01/30/1990SE |
| K896503 | Porges Ercp CathetersFGE · Traditional | 01/30/1990SE |
| K896507 | Porges Diathermy SnareKNS · Traditional | 01/29/1990SE |
| K896425 | Porges Cytology BrushesFDX · Traditional | 01/29/1990SE |
| K896506 | Porges Endoscopic Dormia Extractors, DormiatriptorFGE · Traditional | 01/26/1990SE |
| K896504 | Porges 2-WAY Balloon Extraction CatheterFGE · Traditional | 01/26/1990SE |
| K896424 | Porges Sclerotherapy NeedlesFBK · Traditional | 01/26/1990SE |
| K896502 | Porges Biopsy & Foreign Body ForcepsOCZ · Traditional | 01/22/1990SE |
Questions and answers
When was Porges Biliary Stents cleared by the FDA?
Porges Biliary Stents (K896423) received a 510(k) decision of Substantially Equivalent on January 22, 1990, 75 days after the submission was received.
What is the product code of K896423?
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.