# K160766: Ambu USR, Ambu M

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Aug 17, 2016 after 149 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: 8 generations back to K921244 (1992). 42 ancestors in all.
14 later devices descend from it; 1 cites it directly.
2 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021074: Visera Cystovideoscope Olympus Cyf Type V/VA, Olympus America, Inc. (2002) Summary page 4.
- K133538: Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope Olympus Cyf Type VA2, Visera Cysto-NE, Olympus Corporation of the Americas (2014) Summary page 4.
- K072180: Vision-Sciences CST-5000 Video Cystoscope with Endosheath System, Vision-Sciences, Inc. (2007) Summary page 4.
- K130845: Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview, Ambu A/S (2013) Summary page 4.
- K955066: Olympus FG Series Grasping Forceps, Olympus America, Inc. (1996) Summary page 5.

## Most influential descendants
- K193095: Ambu aScope 4 Cysto (2020), 13 descendants of its own
- K222162: Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (2022), 1 descendant of its own
- K222602: Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) (2022), 1 descendant of its own
- K212202: WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System (2022), 1 descendant of its own
- K251140: Zenflow Spring Scope (2025), 0 descendants of its own

## Indications for use
Ambu® USR is a sterile, single use flexible cystoscope designed for removal of double loop ureteral stents accessible in the bladder via a urethral insertion in adults. Ambu® USR has been designed to be used with the reusable Ambu® M to visualize the observations obtained by Ambu® USR.

Source page: https://510kreport.com/device/K160766
Methodology: https://510kreport.com/methodology