510(k) · Cleared
Recalled · Class II · 2016Spy Scope Intra-Operative Operating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novadaq Technologies, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 9, 2009 as substantially equivalent to K073088 (Novadaq Technologies, Inc., 2008) and 5 other predicates after a 48-day review. Its family tree reaches back 6 generations to 1994. 106 later devices descend from it. It has been recalled once.
- Decided
- Jul 9, 2009
- Review
- 48 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 6 generations to K944261 (1994). 22 ancestors in all, the oldest K910132 (1991). 106 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 5 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 4 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- 3 generations backK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 2 generations backK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 1 generation backK073088 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
- This deviceK091515 Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009
- Descendant · cites it directly · 104 of its ownK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 103 of its ownK124031 DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013
- Descendant · 2 generations on · 87 of its ownK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 76 of its ownK142310 Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy · 2014
- Descendant · cites it directly · 70 of its ownK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 106 · See all- K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · cites it directly104descendants
- K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013 · 2 generations on103descendants
- K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · 2 generations on87descendants
- K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy · 2014 · 3 generations on76descendants
- K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · cites it directly70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −5 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −4 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| −3 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −2 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −1 | K073088 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2008 | — |
| 0 (this device) | K091515 | Spy Scope Intra-Operative Operating System | Novadaq Technologies, Inc. | 2009 | — |
| +1 | K101077 | DA Vinci Fluorescence Imaging Vision System, Model FF 100 | Intuitive Surgical, Inc. | 2011 | 2 |
| +2 | K124031 | DA Vinci Fluorescence Imaging Vision System | Intuitive Surgical, Inc. | 2013 | — |
| +2 | K141077 | DA Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2014 | 2 |
| +3 | K142310 | Stryker Infrared Fluorescence (IRF) Imaging System | Stryker Endoscopy | 2014 | — |
| +1 | K150956 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 7 | 0 |
| 2021 | 9 | 0 |
| 2022 | 11 | 0 |
| 2023 | 14 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 18 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073088 | Spy Fluorescent Imaging SystemSummary page 1…fundamental functional characteristics and indications for use of these predicate devices and components. Imaging Technology Novadaq SPY Intra-operative Imaging System (K073088) Leica FL800 (K061871) Endoscope Stryker Laparoscope (K910132) Circon ACMI USA Series Laparoscope (KO13165) Camera and Light Sour… | 2008 |
| * | K061871 | Leica Model FL800Summary page 1…l characteristics and indications for use of these predicate devices and components. Imaging Technology Novadaq SPY Intra-operative Imaging System (K073088) Leica FL800 (K061871) Endoscope Stryker Laparoscope (K910132) Circon ACMI USA Series Laparoscope (KO13165) Camera and Light Source Linvatec HD Digital… | 2006 |
| * | K910132 | Stryker LaparoscopeSummary page 1…e of these predicate devices and components. Imaging Technology Novadaq SPY Intra-operative Imaging System (K073088) Leica FL800 (K061871) Endoscope Stryker Laparoscope (K910132) Circon ACMI USA Series Laparoscope (KO13165) Camera and Light Source Linvatec HD Digital Camera System (K063457) Circon Metal Ha… | 1991 |
| * | K013165 | Usa Series Laparoscopes | 2002 |
| * | K063457 | Truehd (1080P) Digital Camera SystemSummary page 1…88) Leica FL800 (K061871) Endoscope Stryker Laparoscope (K910132) Circon ACMI USA Series Laparoscope (KO13165) Camera and Light Source Linvatec HD Digital Camera System (K063457) Circon Metal Halide Light Source (K012265)… | 2006 |
| * | K012265 | Metal Halide Light Source, Models MV-9088-T, MV-9088Summary page 1…Laparoscope (K910132) Circon ACMI USA Series Laparoscope (KO13165) Camera and Light Source Linvatec HD Digital Camera System (K063457) Circon Metal Halide Light Source (K012265) 1 NOVADAQ Technologies In… | 2001 |
What descends from it? (106)
See all 1063 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2016 | Class II | Z-1032-2016 | Process design | 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 reprocessing tray. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 22 ancestors have a recall of any class.
- Of its descendants, K101077 (Intuitive Surgical, Inc., 2011) has gone furthest, with 104 descendants of its own.
- 4 other devices also cite its predicate K073088.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091515: Spy Scope Intra-Operative Operating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091515
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026