# K791182: Acmi Rigi-Flex Nephorscope

- Pathway: 510(k) (Traditional)
- Applicant: American Cystocope Makers, Inc.
- Decided: Jul 30, 1979 after 35 days
- Product code: FGA (Kit, Nephroscope)
- 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
No predicates in its family tree.
24 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K791182
Methodology: https://510kreport.com/methodology