# K013153: Autotome RX Model # 4515, 4516

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Oct 19, 2001 after 29 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 32 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970053 (1997). 1 ancestor in all.
43 later devices descend from it; 9 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970053: Ultratomerx, Boston Scientific Corp (1997) Summary page 1.

## Most influential descendants
- K022595: Wilson-Cook Cystotome (2002), 29 descendants of its own
- K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A (2009), 16 descendants of its own
- K123676: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes (2013), 11 descendants of its own
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K141358: Cellvizio 100 Series with System Confocal Miniprobes (2014), 9 descendants of its own

## Recalls of this device
- Jun 12, 2024 · Class II · Z-2350-2024: Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
- Dec 22, 2021 · Class II · Z-0753-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0761-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0770-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0772-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0775-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0779-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0780-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0781-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0751-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0752-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0758-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0762-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0763-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0766-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0768-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0776-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0777-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0778-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0769-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0774-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0754-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0755-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0756-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0757-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0759-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0760-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0764-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0765-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0767-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0771-2022: Sterility of device is compromised due to a sterile barrier breach
- Dec 22, 2021 · Class II · Z-0773-2022: Sterility of device is compromised due to a sterile barrier breach

## Indications for use
The Autotome™ RX is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to cannulate and inject contrast medium.

Source page: https://510kreport.com/device/K013153
Methodology: https://510kreport.com/methodology