Single-use Video Pancreaticobiliary Scope, PB Digital Controller (K221784)
Description
Single-use Video Pancreaticobiliary Scope, PB Digital Controller by Micro-Tech (Nanjing) Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
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Predicate lineage for K221784
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Single-use Video Pancreaticobiliary Scope, PB Digital Controller (K221784) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200483 | SpyGlass Discover Digital Catheter, SpyGlass Discover Digit... | Boston Scientific Corporation | 2020 |
| K142922 | SpyGlass DS Direct Visualization System | Boston Scientific Corporation | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K252492 | Visualized Access and Delivery Catheter; PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | 2026 |
Trace the full predicate network for K221784
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.