# K023358: Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8

- Pathway: 510(k) (Traditional)
- Applicant: Acmi Corporation
- Decided: Jan 3, 2003 after 88 days
- Product code: FGB (Ureteroscope 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: 1 generation back to K971977 (1997). 4 ancestors in all.
101 later devices descend from it; 2 cite it directly.
1 of 106 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012951: Apn-2 Usa Series Flexible Choledochoscope, Circon Video (2001)
- K972926: MVM 7.5 French Flexible Choledochoscope, KARL STORZ Endoscopy-America, Inc. (1997) Summary page 1.
- K971977: Ksea 15.5 FR. Flexible Choledocho-Fiberscope, KARL STORZ Endoscopy-America, Inc. (1997) Summary page 1.
- K012925: Dur-8, Models Dur-8, Circon Video (2001)

## Most influential descendants
- 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
- K072594: Gyrus Acmi Ipn-2505, Invisio  Smith Percutaneous  Nephroscope System (2007), 23 descendants of its own

## Indications for use
The ACMI USA Series™ DUR-8 and DUR-8Elite (DUR-8E) Flexible Ureteropyeloscope and Choledochoscope are indicated for therapeutic and diagnostic procedures in the entire intrarenal collecting system. The DUR-8 and DUR-8E are also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Source page: https://510kreport.com/device/K023358
Methodology: https://510kreport.com/methodology