510(k) K253987

Device: BARE Wireguided Balloon Dilation Catheter (1235)
Applicant: GIE Medical
510(k) number: K253987
Product code: FGE
Decision: Substantially Equivalent (SESE)
Decision date: 2026-03-13
Date received: 2025-12-12
Regulation: 876.5010
Classification name: Stents, Drains And Dilators For The Biliary Ducts
Medical specialty: Gastroenterology, Urology
Review panel: Gastroenterology, Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Ian Schorn
Address: 7601 Northland Dr. N, Suite 170 Brooklyn Park MN US 55428 55428

FDA Registration Numbers

1450395
3014769442
1061124
3004129994
3002504068
3014328942
3035451914
3006131984
2183870
2183744
1222168
3012536737
3006260740
2032098
1644312
2134265
3001845648
3003910212
3011347300
3030447506
3011050570
3013557562
9616099
2024168
2246552
9616684
1225687
3031276312
1721676
1820334
2939561
3033589330
3006950086
1317547
3005099803
3013162291
3005089785
2126666
2024024
3002807314
1018233
1417485
9710284
1223925
3021009035
1828132
3030733800
1037905
1531050
3013337852
1625425
3008146331
3013152301
3014279513
3040505963
3010155661
9680809
1058584
3011146996
3008040402
3009526575
3014579161
3007695959
1928237
1000393132
3012480535
1724474
1319639
3004091615
3011458193
9681477
3009763019
3021632375
9614641
3008492676
3013460719
2030624
3009018440
3030446844
3027260597

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FGE

510(k)	Device	Applicant	Decision date
K253832	Dilation Balloon Catheter	Mirco-Tech (Nanjing) Co., Ltd.	2026-04-24
K251658	Endoflux Biliary & Pancreatic Stent Sets	Medi-Globe GmbH	2026-04-16
K253132	Single use stone retrieval balloons	Zhejiang Chuangxiang Medical Technology Co., Ltd.	2026-03-06
K251123	Niti-S Biliary Stent; Niti-S Biliary Slim M Stent	Taewoong Medical Co., Ltd.	2025-12-29
K251019	BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G	Bioteque Corporation	2025-12-22
K250409	Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)	Olympus Medical Systems Corporation	2025-10-21
K251229	EndoFixTissue Fixation System	Softac Medical Technologies	2025-08-20
K243412	ARCHIMEDES Biodegradable Pancreatic Stent	Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)	2025-07-16
K251291	Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers	Boston Scientific	2025-07-03
K242845	EGIS Biliary Double Bare Stent (BDB080405)	S&G Biotech, Inc.	2025-06-25
K241888	Single-use Balloon Dilatation Catheter	Leo Medical Co., Ltd.	2024-12-20
K241801	Tornus ES	Asahi Intecc Co., Ltd.	2024-12-17
K242950	WallFlex Biliary PLUS RX Stent System	Boston Scientific	2024-12-06
K240464	WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV	Boston Scientific	2024-08-30
K233079	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)	Cook Ireland, Ltd.	2024-06-14