Atlas FDA

SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller

FDA 510(k) clearance K183636 · decided 2019-01-22

Clearance details

K-number
K183636
Device name
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2018-12-26
Decision date
2019-01-22
Days to decision
27 days
Clearance type
Special
Product code
FBN
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Boston Scientific Corporation

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Single-use Video Scope; PB Digital Controller (K254153)Mirco-Tech (Nanjing) Co., Ltd.2026-04-03
Disposable Distal Cap (K253139)Mirco-Tech (Nanjing) Co., Ltd.2026-03-19
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) (K251338)Scivita Medical Technology Co., Ltd.2026-01-20
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller (K251170)Tangent Endoscopy, LLC2025-09-12
Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) (K243535)Shanghai SeeGen Photoelectric Technology Co., Ltd.2025-03-07
Biliary Pancreaticobiliary Scope System (K241444)Shenzhen HugeMed Medical Technical Development Co., Ltd.2025-01-21
Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps (K233752)CenterPoint Systems, LLC2024-05-02
Choledochoscope System (K231497)Shenzhen HugeMed Medical Technical Development Co., Ltd.2024-03-06
Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) (K231105)Shanghai AnQing Medical Instrument Co., Ltd.2023-10-17
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) (K223741)Zhuhai Pusen Medical Technology Co., Ltd.2023-06-22
Flexible Video-Choledochoscope System (K222261)Shanghai SeeGen Photoelectric Technology Co., Ltd.2023-04-20
Single-use Video Pancreaticobiliary Scope, PB Digital Controller (K221784)Micro-Tech (Nanjing) Co., Ltd.2023-02-16

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Axonics Sacral Neuromodulation System (P190006/S101)Boston Scientific Corporation2025-12-19
Axonics Sacral Neuromodulation System (P180046/S101)Boston Scientific Corporation2025-12-19
SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S110)Boston Scientific Corporation2025-10-29
Innova™ Vascular Self-Expanding Stent System (P140028/S084)Boston Scientific Corporation2025-10-24
Ranger™ Paclitaxel-Coated PTA Balloon Catheter (P190019/S039)Boston Scientific Corporation2025-10-24
AGENT™ Paclitaxel-Coated Balloon Catheter (P230035/S007)Boston Scientific Corporation2025-10-24
ENROUTE® Transcarotid Stent System (P140026/S032)Boston Scientific Corporation2025-10-23
A209 SICD Gen 2,A219 SICD MRI (P110042/S206)Boston Scientific Corporation2025-10-22