# K052044: Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6AL

- Pathway: 510(k) (Special)
- Applicant: Acmi Corporation
- Decided: Aug 16, 2005 after 19 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 K011849 (2001). 1 ancestor in all.
25 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011849: Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642) Ureteroscopes, Mro-7 Series (Mro-733) Ureteros, Circon Video (2001) Summary page 1.

## Most influential descendants
- K072594: Gyrus Acmi Ipn-2505, Invisio  Smith Percutaneous  Nephroscope System (2007), 23 descendants of its own
- K092278: Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4 (2009), 22 descendants of its own
- K123151: Endosee Model 8000 U-Scope (2013), 20 descendants of its own
- K132384: U-Scope 8000 System with HSC+Emb Cannula (2014), 19 descendants of its own
- K170660: Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula (2017), 5 descendants of its own

## Indications for use
The ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes are intended for the examination/operation of the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K052044
Methodology: https://510kreport.com/methodology