# K010610: Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Mar 27, 2001 after 26 days
- Product code: ODC (Endoscope Channel Accessory)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970054 (1997). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970052: Extractorrx, Boston Scientific Corp (1997) Summary page 5.
- K970053: Ultratomerx, Boston Scientific Corp (1997) Summary page 5.
- K970054: Tandemrx, Boston Scientific Corp (1997) Summary page 5.

## Most influential descendants
- K040137: Wilson-Cook Usw Cap and Wire Lock (2004), 4 descendants of its own
- K213483: SnapLoc Wire Lock (2022), 0 descendants of its own
- K220247: Guidewire Locking Device (2022), 0 descendants of its own
- K210353: AutoCap RX (2021), 0 descendants of its own
- K202237: Locking device (2020), 0 descendants of its own

## Indications for use
The Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System consists of two accessories intended for use with Microvasive® Biliary Rapid Exchange™ devices: The Microvasive® Rapid Exchange™ Locking Device is intended to lock the guidewire in place during ERCP procedures. The Microvasive® Rapid Exchange™ Biopsy Cap is intended to facilitate the use of Rapid Exchange™ devices during ERCP procedures.

Source page: https://510kreport.com/device/K010610
Methodology: https://510kreport.com/methodology