Navarre Percutaneous Biliary Drainage
FDA 510(k) K955110 · Navarre Biomedical , Ltd.
510(k) numberK955110
Submission
- Device name
- Navarre Percutaneous Biliary Drainage
- Applicant
- Navarre Biomedical , Ltd.
Plymouth, MN, US - Received
- November 8, 1995
- Decision date
- November 7, 1996
- Decision
- Substantially Equivalent (SESE)
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K955505 | Opti-Drain Multi-Use Drainage CatheterGBX · Traditional | 02/07/1996SE |
| K945909 | Navarre N-Fuser(Tm) Peripheral Infusion CatheterKRA · Traditional | 06/02/1995SE |
| K951907 | Navarre Locking Pigtail Universal Drainage CatheterGBX · Traditional | 05/15/1995SE |
| K951475 | Navarre Universal Drainage CatheterGBX · Traditional | 04/24/1995SE |
| K943663 | Navarre 600 ML Drainage BagEXF · Traditional | 09/08/1994SE |
| K942315 | Navarre Percutaneous Access SetKGZ · Traditional | 07/08/1994SE |
| K933600 | Navarre Biomedical Tip-Locking Drainage CathetersGBX · Traditional | 03/28/1994SE |
| K932391 | Navarre Biomedical Universal Drainage Catheter SetGBX · Traditional | 01/27/1994SE |
Questions and answers
When was Navarre Percutaneous Biliary Drainage cleared by the FDA?
Navarre Percutaneous Biliary Drainage (K955110) received a 510(k) decision of Substantially Equivalent on November 7, 1996, 365 days after the submission was received.
What is the product code of K955110?
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.