Wiltek Biliary Stent Set
FDA 510(k) K894871 · Wiltek Medical, Inc.
510(k) numberK894871
Submission
- Device name
- Wiltek Biliary Stent Set
- Applicant
- Wiltek Medical, Inc.
Winston-Salem, NC, US - Received
- July 31, 1989
- Decision date
- December 21, 1989
- 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 |
|---|---|---|
| K990231 | Wiltek Hot Biopsy ForcepsKGE · Traditional | 04/13/1999SE |
| K922989 | Wiltek Irrigaiton/Aspiration Tube SetBYY · Traditional | 02/15/1994SE |
| K930419 | Wiltek Biopsy ForcepsBWH · Traditional | 06/01/1993SE |
| K914882 | Wiltek Balloon Cholangiography CatheterFGE · Traditional | 01/07/1992SE |
| K914881 | Wiltek Laparoscopic Cholangiography CatheterFGE · Traditional | 01/07/1992SE |
| K914132 | Wiltek Electrocautery Active CordGEI · Traditional | 09/25/1991SE |
| K914131 | Wiltek Electrocautery AdaptorGEI · Traditional | 09/25/1991SE |
| K912288 | Wiltek Standard Cholangiography CatheterFGE · Traditional | 09/23/1991SE |
| K912122 | Cholangiography CatheterFGE · Traditional | 09/23/1991SE |
| K910334 | Electrocautery ProbeGEI · Traditional | 02/21/1991SE |
Questions and answers
When was Wiltek Biliary Stent Set cleared by the FDA?
Wiltek Biliary Stent Set (K894871) received a 510(k) decision of Substantially Equivalent on December 21, 1989, 143 days after the submission was received.
What is the product code of K894871?
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.