510(k) K905229
- Device
- LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS
- Applicant
- ARROW INTL., INC.
- 510(k) number
- K905229
- Product code
- FGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-01-18
- Date received
- 1990-11-20
- 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
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS NICKEL
- Address
- P.O. Box 6306 Hill And George Ave.S Reading PA US 19610 19610
FDA Registration Numbers#
- 3010532612
- 1724474
- 3006082230
- 3007146453
- 1016427
- 3010220595
- 3008146331
- 3016678045
- 3030446844
- 3013162291
- 3009051888
- 1225687
- 3013526170
- 9680794
- 3011347300
- 3004111573
- 3012536737
- 2011171
- 3009121749
- 2126666
- 3005099803
- 3008040402
- 1037905
- 3030733800
- 3014769442
- 1058584
- 3011137372
- 9616684
- 3031276312
- 1313046
- 3040096051
- 3011689956
- 3011050570
- 2648045
- 3011163668
- 3014222368
- 3035451914
- 2183870
- 2134265
- 3014579161
- 3012480535
- 1319211
- 3011458193
- 9680809
- 2032098
- 1450395
- 3004207966
- 3021632375
- 3003775027
- 3009906660
- 2029386
- 1721504
- 3004859241
- 1319639
- 2246552
- 2024024
- 1721676
- 3010173425
- 2939561
- 2020394
- 3003898360
- 1219930
- 2030624
- 3009763019
- 3007695959
- 1928237
- 3006891655
- 3013460719
- 3010155661
- 3013152301
- 3003790304
- 3009526575
- 1828132
- 3006131984
- 3030447506
- 3032916632
- 3033589330
- 1417485
- 3010273872
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FGE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253393 | 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 | Hangzhou AGS MedTech Co., Ltd. | 2026-06-24 |
| K253832 | Dilation Balloon Catheter | Mirco-Tech (Nanjing) Co., Ltd. | 2026-04-24 |
| K251658 | Endoflux™ Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | 2026-04-16 |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235) | GIE Medical | 2026-03-13 |
| 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 | EndoFix™Tissue 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 |
Legacy Summary#
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FDA Review#
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