# K210353: AutoCap RX

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: May 6, 2021 after 87 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: 2 generations back to K970054 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010610: Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527, Boston Scientific Corp (2001) Summary page 5.

## Indications for use
The AutoCap RX Integrated Biopsy Cap and Guidewire Locking Device is intended to facilitate placement of the guidewire and lock it into place during ERCP procedures. The device also provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the ERCP procedure, and provides access for irrigation.

Source page: https://510kreport.com/device/K210353
Methodology: https://510kreport.com/methodology