# K072594: Gyrus Acmi Ipn-2505, Invisio  Smith Percutaneous  Nephroscope System

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Dec 13, 2007 after 90 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
Longest line of descent: 7 generations back to K931154 (1993). 25 ancestors in all.
23 later devices descend from it; 1 cites it directly.
1 of 49 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060269: Acmi Dur-Digital Ureteroscope and Choledochoscope System, Acmi Corporation (2006) Summary page 1.
- K791182: Acmi Rigi-Flex Nephorscope, American Cystocope Makers, Inc. (1979) Summary page 1.
- K052044: Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6AL, Acmi Corporation (2005) Summary page 1.

## Most influential descendants
- 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
- K202445: Hystero-V Hysteroscope (2021), 4 descendants of its own

## Indications for use
The Gyrus ACMI® IPN-2505, Invisio® SmithTM Percutaneous Nephroscope System (which includes the IPN-2505 Invisio® SmithTM Percutaneous Nephroscope and IDC-1500 Invisio® Camera Control Unit) is intended for close visualization of the urinary bladder, renal pelvis and major calyces. The IPN-2505 can be introduced through a percutaneous tract into the kidney and can also be introduced through the urethra to access the bladder. Additional accessories can be used to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K072594
Methodology: https://510kreport.com/methodology