510(k) K183636
- Device
- SpyScope DS Access And Delivery Catheter, SpyScope DS II Access And Delivery Catheter, SpyGlass DS Digital Controller
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K183636
- Product code
- FBN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-01-22
- Date received
- 2018-12-26
- Regulation
- 876.1500
- Classification name
- Choledochoscope And Accessories, Flexible/rigid
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Carter Navarro
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers#
- 3003782610
- 3038296436
- 3015139943
- 3013247477
- 3022106566
- 3014498758
- 3041659934
- 9616693
- 9610877
- 9610617
- 8010047
- 3013440400
- 3010202439
- 9611102
- 2020550
- 3004837686
- 9681260
- 9614641
- 3008386005
- 3015807001
- 3005099803
- 1225687
- 2024311
- 3011050570
- 3014342096
- 1221826
- 3015970743
- 3028058843
- 1828132
- 3020369549
- 3013992977
- 1000121056
- 3010273872
- 3036978610
- 1418479
- 3002808148
- 3012797688
- 3013687468
- 1422634
- 3003018722
- 3014769442
- 3010707607
- 2183744
- 9610595
- 3003790304
Source Documents#
Other 510(k) Records For Product Code FBN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254153 | Single-use Video Scope; PB Digital Controller | Mirco-Tech (Nanjing) Co., Ltd. | 2026-04-03 |
| K253139 | Disposable Distal Cap | Mirco-Tech (Nanjing) Co., Ltd. | 2026-03-19 |
| K251338 | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) | Scivita Medical Technology Co., Ltd. | 2026-01-20 |
| K251170 | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller | Tangent Endoscopy, LLC | 2025-09-12 |
| K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2025-03-07 |
| K241444 | Biliary Pancreaticobiliary Scope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2025-01-21 |
| K233752 | Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps | CenterPoint Systems, LLC | 2024-05-02 |
| K231497 | Choledochoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-03-06 |
| K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2023-10-17 |
| K223741 | Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) | Zhuhai Pusen Medical Technology Co., Ltd. | 2023-06-22 |
| K222261 | Flexible Video-Choledochoscope System | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2023-04-20 |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | 2023-02-16 |
| K200483 | SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller | Boston Scientific Corporation | 2020-05-21 |
| K181439 | SpyGlass DS and DS II Direct Visualization System | Boston Scientific Corporation | 2018-08-23 |
| K161147 | EndoCure Model EUR078A | Endocure Technologies, Inc. | 2016-06-07 |
Legacy Summary#
summary
FDA Review#
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