# K230127: Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Sep 6, 2023 after 232 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K851962 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172044: Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S, Cook Ireland, Ltd. (2018) Summary page 7.

## Indications for use
The Biliary Plastic Stent is used to drain obstructed biliary ducts. The Biliary Plastic Stent Introducer is used for endoscopic biliary stent placement. The Biliary Plastic Stent Introducer/ short-wire compatible is used for endoscopic biliary stent placement. The Biliary Plastic Stent Set is intended for endoscopic biliary stent placement to drain obstructed bile ducts. The Biliary Plastic Stent Set/ short-wire compatible is intended for endoscopic biliary stent placement to drain obstructed bile ducts.

Source page: https://510kreport.com/device/K230127
Methodology: https://510kreport.com/methodology