510(k) K914881
- Device
- WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
- Applicant
- WILTEK MEDICAL, INC.
- 510(k) number
- K914881
- Product code
- FGE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-01-07
- Date received
- 1991-10-30
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JON S WILSON
- Address
- P.O.Box 11946 Winston-Salem NC US 27116 27116
FDA Registration Numbers#
- 3013557562
- 3011163668
- 3016678045
- 3005580113
- 3000247987
- 3021632375
- 3003910212
- 1724474
- 1643817
- 3005941719
- 3006131984
- 3009763019
- 3014769442
- 3009051888
- 2024168
- 3013152301
- 3013247477
- 1528319
- 3012480535
- 3013526170
- 3010155661
- 3005099803
- 1317547
- 3010173425
- 3014328942
- 3010419931
- 1531050
- 3007695959
- 2032098
- 1018233
- 3005987240
- 1037905
- 9616684
- 3027260597
- 1319211
- 3002807314
- 2029386
- 1828132
- 2183744
- 1417485
- 3021009035
- 2134265
- 3035451914
- 1313046
- 3004837686
- 3011137372
- 2126666
- 9710641
- 1061124
- 9616099
- 3006950086
- 3004111573
- 3010220595
- 3003775027
- 1016427
- 3030447506
- 3033589330
- 1000393132
- 3016463905
- 3032916632
- 1450395
- 3006260740
- 9680794
- 3011347300
- 3013162291
- 3031276312
- 3013440400
- 2024024
- 1000121056
- 3005089785
- 2939561
- 2030624
- 3011642792
- 9681260
- 3009121749
- 3001845648
- 3014222368
- 2124215
- 9680809
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FGE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260835 | ARCHIMEDES Biodegradable Stent (Medium) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2026-07-27 |
| 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 |
Legacy Summary#
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FDA Review#
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