2 Lumen Endos Retro Cholangiopancrea Injec Cath
FDA 510(k) K913841 · Endovations
510(k) numberK913841
Submission
- Device name
- 2 Lumen Endos Retro Cholangiopancrea Injec Cath
- Applicant
- Endovations
Mechanicsburg, PA, US - Received
- August 26, 1991
- Decision date
- October 8, 1991
- Decision
- Substantially Equivalent (SESE)
- 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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| 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 |
|---|---|---|
| K955413 | Endovations Triple Lumen Balloon Dilatation CatheterFGE · Traditional | 02/08/1996SE |
| K942110 | Inject-SnareFDI · Traditional | 10/13/1994SE |
| K944049 | Oxygen MouthguardMNK · Traditional | 10/11/1994SE |
| K934315 | Endovations(R) .035 Pre-Cut PapillatomeKNS · Traditional | 02/28/1994SE |
| K913870 | 5MM MicroscissorsGCJ · Traditional | 09/16/1991SE |
| K911155 | Oval Cup Biopsy ForcepFCF · Traditional | 08/07/1991SE |
| K892218 | Endo-SpongeMNL · Traditional | 05/31/1989SE |
| K883093 | Transendoscopic Aspiration NeedleFBK · Traditional | 12/08/1988SE |
| K873360 | Enteron Percutan. Endoscopic Gastrostomy Tray-PegKNT · Traditional | 03/30/1988SE |
| K875264 | Washing CatheterOCX · Traditional | 03/29/1988SE |
Questions and answers
When was 2 Lumen Endos Retro Cholangiopancrea Injec Cath cleared by the FDA?
2 Lumen Endos Retro Cholangiopancrea Injec Cath (K913841) received a 510(k) decision of Substantially Equivalent on October 8, 1991, 43 days after the submission was received.
What is the product code of K913841?
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.