# K030960: Ecn Electronic Video Cystonephroscope

- Pathway: 510(k) (Traditional)
- Applicant: Acmi Corporation
- Decided: Jul 16, 2003 after 111 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- 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: 4 generations back to K931154 (1993). 15 ancestors in all.
103 later devices descend from it; 2 cite it directly.
2 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904797: Surgitek Graduated Cystoscope (Model GC-16), Surgitek (1991) Summary page 2.
- K012951: Apn-2 Usa Series Flexible Choledochoscope, Circon Video (2001) Summary page 2.
- K021074: Visera Cystovideoscope Olympus Cyf Type V/VA, Olympus America, Inc. (2002) Summary page 2.
- K951191: FCN-15X, Fiber Choledochonephroscope, Pentax Precision Instrument Corp. (1995) Summary page 2.
- K010489: Dyonics Vision 111 Mobile Video Unit, Smith & Nephew, Inc. (2001)

## Most influential descendants
- K042225: Acmi Invisio Icn, Models Icn-0564 and Icn-0565 (2004), 101 descendants of its own
- K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System (2006), 99 descendants of its own
- K131369: Flexible Video-Uretero-Renoscope System (2013), 53 descendants of its own
- K153049: LithoVue System (2015), 24 descendants of its own
- K172098: Medical Video Endoscope System (2017), 23 descendants of its own

## Indications for use
The ACMI Electronic Video CystoNephroscope (ECN) System is a flexible endoscopic surgical video system consisting of an endoscope, CMOS video sensor and light source mounted in the endoscope, and a Controller unit. This system is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures

Source page: https://510kreport.com/device/K030960
Methodology: https://510kreport.com/methodology