# K091515: Spy Scope Intra-Operative Operating System

- Pathway: 510(k) (Traditional)
- Applicant: Novadaq Technologies, Inc.
- Decided: Jul 9, 2009 after 48 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K944261 (1994). 22 ancestors in all.
106 later devices descend from it; 3 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073088: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2008) Summary page 1.
- K061871: Leica Model FL800, Leica Microsystems, Inc. (2006) Summary page 1.
- K910132: Stryker Laparoscope, Stryker Corp. (1991) Summary page 1.
- K013165: Usa Series Laparoscopes, Circon Acmi (2002)
- K063457: Truehd (1080P) Digital Camera System, Conmed Linvatec (2006) Summary page 1.
- K012265: Metal Halide Light Source, Models MV-9088-T, MV-9088, Circon Video (2001) Summary page 1.

## Most influential descendants
- K101077: DA Vinci Fluorescence Imaging Vision System, Model FF 100 (2011), 104 descendants of its own
- K124031: DA Vinci Fluorescence Imaging Vision System (2013), 103 descendants of its own
- K141077: DA Vinci Firefly Imaging System (2014), 87 descendants of its own
- K142310: Stryker Infrared Fluorescence (IRF) Imaging System (2014), 76 descendants of its own
- K150956: PINPOINT Endoscopic Fluorescence Imaging System (2016), 70 descendants of its own

## Recalls of this device
- Jan 29, 2016 · Class II · Z-1032-2016: It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the rep

## Indications for use
The SPY scope intra-operative imaging system (SPY scope) is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. SPY scope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery.

Source page: https://510kreport.com/device/K091515
Methodology: https://510kreport.com/methodology