Chrysalis Intelligence · Product Codes · FGE

FGE · Stents, Drains And Dilators For The Biliary Ducts

Gastroenterology, Urology · 36 clearances · 21 unique sponsors

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Device class
Class II
Regulation 876.5010
Total clearances
36
2020-06-26 → 2026-07-27
Last 12 months
9
Unique sponsors
21
Classification details
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.5010
Implant
Y
Life-sustain / support
Y
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Boston Scientific 6 0 2025-07-03
Bioteque Corporation 3 1 2025-12-22
Taewoong Medical Co., Ltd. 3 1 2025-12-29
Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) 2 1 2026-07-27
Endogi Medical, Ltd. 2 0 2023-09-27
Cook Ireland, Ltd. 2 0 2024-06-14
Endo GI Medical 2 0 2022-09-28
Micro-Tech (Nanjing) Co., Ltd. 2 0 2023-09-06
S&G Biotech, Inc. 2 0 2025-06-25
Hangzhou AGS MedTech Co., Ltd. 1 1 2026-06-24
Softac Medical Technologies 1 0 2025-08-20
Asahi Intecc Co., Ltd. 1 0 2024-12-17
Olympus Medical Systems Corporation 1 1 2025-10-21
GIE Medical 1 1 2026-03-13
Medi-Globe GmbH 1 1 2026-04-16
Mirco-Tech (Nanjing) Co., Ltd. 1 1 2026-04-24
M.I.Tech Co., Ltd. 1 0 2021-05-11
Zhejiang Chuangxiang Medical Technology Co., Ltd. 1 1 2026-03-06
Jiangsu Vedkang Medical Science and Technology Co., Ltd. 1 0 2024-02-15
Dongguan TT Medical, Inc. 1 0 2023-03-09
Leo Medical Co., Ltd. 1 0 2024-12-20
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
43262 CPT — High ERCP with placement of stent in biliary ductal system
47555 CPT — High Percutaneous transhepatic cholangiography with stent or drain placement for biliary ductal procedures
47556 CPT — High Biliary catheter or stent placement and exchange
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-27 K260835 Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) ARCHIMEDES Biodegradable Stent (Medium)
2026-06-24 K253393 Hangzhou AGS MedTech Co., Ltd. Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019
2026-04-24 K253832 Mirco-Tech (Nanjing) Co., Ltd. Dilation Balloon Catheter
2026-04-16 K251658 Medi-Globe GmbH Endoflux™ Biliary & Pancreatic Stent Sets
2026-03-13 K253987 GIE Medical BARE Wireguided Balloon Dilation Catheter (1235)
2026-03-06 K253132 Zhejiang Chuangxiang Medical Technology Co., Ltd. Single use stone retrieval balloons
2025-12-29 K251123 Taewoong Medical Co., Ltd. Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
2025-12-22 K251019 Bioteque Corporation BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
2025-10-21 K250409 Olympus Medical Systems Corporation Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
2025-08-20 K251229 Softac Medical Technologies EndoFix™Tissue Fixation System
2025-07-16 K243412 Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) ARCHIMEDES Biodegradable Pancreatic Stent
2025-07-03 K251291 Boston Scientific Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
2025-06-25 K242845 S&G Biotech, Inc. EGIS Biliary Double Bare Stent (BDB080405)
2024-12-20 K241888 Leo Medical Co., Ltd. Single-use Balloon Dilatation Catheter
2024-12-17 K241801 Asahi Intecc Co., Ltd. Tornus ES
2024-12-06 K242950 Boston Scientific WallFlex Biliary PLUS RX Stent System
2024-08-30 K240464 Boston Scientific WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
2024-06-14 K233079 Cook Ireland, Ltd. Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)
2024-02-15 K232245 Jiangsu Vedkang Medical Science and Technology Co., Ltd. VedDilator ^TM (3-Stage Balloon Dilation Catheter)
2023-09-27 K232596 Endogi Medical, Ltd. EndoGI S-Path Biliary Stent System
2023-09-21 K223354 S&G Biotech, Inc. EGIS Biliary Single Bare Stent
2023-09-06 K230127 Micro-Tech (Nanjing) Co., Ltd. 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
2023-06-15 K223469 Boston Scientific Corporation WallFlex™ Biliary RX Stent System
2023-05-26 K223626 Taewoong Medical Co., Ltd. Niti-S Biliary Speed D Stent
2023-03-09 K222663 Dongguan TT Medical, Inc. MultiStage Balloon Dilatation Catheter
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence