510(k) Report

510(k) · Cleared

Cleared

PINPOINT Endoscopic Fluorescence Imaging System

K182606510(k) TraditionalCleared Nov 21, 201861-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Novadaq Technologies Ulc. (Now A Part of Stryker) · GCJ Laparoscope, General & Plastic Surgery

Cleared on Nov 21, 2018 as substantially equivalent to K150956 (Novadaq Technologies, Inc., 2016) and 1 other predicate after a 61-day review. Its family tree reaches back 17 generations to 1994. 44 later devices descend from it.

Decided
Nov 21, 2018
Review
61 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
2

Its longest line of descent runs back 17 generations to K930667 (1994). 85 ancestors in all, the oldest K811390 (1981). 44 later devices descend from it, 12 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2009: 1 other ancestor2013: 2 other ancestors2011: 1 other ancestor2008: 1 other ancestor2006: 5 other ancestors2002: 4 other ancestors2001: 6 other ancestors1991: 4 other ancestors2007: 3 other ancestors2005: 3 other ancestors2003: 2 other ancestors2000: 1 other ancestor1999: 6 other ancestors1998: 3 other ancestors1997: 9 other ancestors1996: 1 other ancestor2004: 4 other ancestors1995: 3 other ancestors1994: 3 other ancestors1993: 2 other ancestors1992: 1 other ancestor1988: 1 other ancestor1981: 1 other ancestor2020: 3 descendants cleared2024: 7 descendants cleared2022: 5 descendants cleared2023: 9 descendants cleared2019: 2 descendants cleared2026: 10 descendants cleared2021: 2 descendants cleared2025: 6 descendants clearedK930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalled×5: 5 generations cleared close together, K040237 (2004), K043153 (2004), K050005 (2005), K050404 (2005), K050802 (2005) K063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK090993 · Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK123463 · Intuitive Surgical DA Vinci SI Surgical System Smartpedals · Intuitive Surgical, Inc. · 2012 · recalled×2: 2 generations cleared close together, K131861 (2014), K141077 (2014) ×2: 2 generations cleared close together, K150956 (2016), K161792 (2016) 19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 9 other ancestors4 generations back: 12 other ancestors5 generations back: 16 other ancestors6 generations back: 8 other ancestors7 generations back: 13 other ancestors8 generations back: 5 other ancestors9 generations back: 3 other ancestors 1 generation forward: 12 descendants2 generations forward: 17 descendants3 generations forward: 11 descendants4 generations forward: 4 descendants K161792 · PINPOINT Endoscopic Fluorescence Imaging System · Novadaq Technologies, Inc. · 2016K150956 · PINPOINT Endoscopic Fluorescence Imaging System · Novadaq Technologies, Inc. · 2016 · recalledK141077 · DA Vinci Firefly Imaging System · Intuitive Surgical, Inc. · 2014 · recalledK131861 · DA Vinci Surgical System, Endowrist Instruments and Accessories · Intuitive Surgical, Inc. · 2014 · recalledK123463 · Intuitive Surgical DA Vinci SI Surgical System Smartpedals · Intuitive Surgical, Inc. · 2012 · recalledK090993 · Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK050802 · Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050404 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050005 · Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180 · Intuitive Surgical, Inc. · 2005 · recalledK043153 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 · Intuitive Surgical, Inc. · 2004K040237 · Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2004K021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalledK990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalled−15−10−50
  1. Root · 17 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 13 generations between
  3. 3 generations backK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
  4. 2 generations backK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
  5. 1 generation backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
  6. This deviceK182606 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018
  7. Descendant · cites it directly · 8 of its ownK200737 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
  8. Descendant · cites it directly · 7 of its ownK202925 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc. · 2020
  9. Descendant · cites it directly · 6 of its ownK191851 VS3-IRMedtronic · 2019
  10. Descendant · cites it directly · 5 of its ownK231854 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light…Stryker · 2023
  11. Descendant · 2 generations on · 5 of its ownK210265 VS3 Iridium SytemVisionsense, Ltd. · 2021
Show all 17 generations
  1. Root · 17 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 16 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 15 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. 14 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. 13 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. 12 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. 11 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. 10 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  9. 9 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  10. 8 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  11. 7 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  12. 6 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
  13. 5 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
  14. 4 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
  15. 3 generations backK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
  16. 2 generations backK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
  17. 1 generation backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
  18. This deviceK182606 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2019: 22020: 32021: 22022: 52023: 92024: 72025: 62026: 10
2019high 10 (2026) · low 2 (2019)2026

Most influential descendants

Showing 5 of 44 · See all
  • K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020 · cites it directly8descendants
  • K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc. · 2020 · cites it directly7descendants
  • K191851VS3-IRMedtronic · 2019 · cites it directly6descendants
  • K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker · 2023 · cites it directly5descendants
  • K210265VS3 Iridium SytemVisionsense, Ltd. · 2021 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−16K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−15K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
−14K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
−13K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
−12K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
−11K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
−10K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
−9K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—
−8K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20064
−7K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200925
−6K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200…Intuitive Surgical, Inc.20093
−5K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20122
−4K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.201480
−3K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20142
−2K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.20161
−1K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016—
0 (this device)K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker)2018—
+1K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)2020—
+1K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.2020—
+1K191851VS3-IRMedtronic2019—
+1K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source…Stryker2023—
+2K210265VS3 Iridium SytemVisionsense, Ltd.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199140
199210
199320
199430
199530
199610
199790
199830
199960
200010
200160
200240
200320
200440
200530
200650
200730
200810
200910
201110
201320
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201920
202030
202120
202250
202390
202470
202560
2026100
FIG. 1 — Lineage of K182606, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K150956PINPOINT Endoscopic Fluorescence Imaging System
Summary page 4
…Fax: (604) 232-9841 Date 510(k) Summary Prepared: November 15, 2018 Predicate Device: PINPOINT Endoscopic Fluorescence Imaging System (K150956 and K161792) (Novadaq Technologies Inc.) Device Description: The PIN…
Novadaq Technologies, Inc.20161
*K161792PINPOINT Endoscopic Fluorescence Imaging System
Summary page 4
…(k) Summary Prepared: November 15, 2018 Predicate Device: PINPOINT Endoscopic Fluorescence Imaging System (K150956 and K161792) (Novadaq Technologies Inc.) Device Description: The PINPOINT Endoscopic Fluorescence Imaging Sys…
Novadaq Technologies, Inc.2016—

Also cleared against K150956: 4 other devices →

What descends from it? (44)

See all 44

12 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208
K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc.20207
K191851VS3-IRMedtronic20196
K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235
K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234
K221861FloNavi Endoscopic Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20232
K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20222
K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191
K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260
K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
  • 26 of the 85 ancestors have a recall of any class.
  • Of its descendants, K200737 (Novadaq Technologies Ulc. (Now A Part of Stryker), 2020) has gone furthest, with 8 descendants of its own.
  • 4 other devices also cite its predicate K150956.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

What is it indicated for?

Upon intravenous administration of TRADENAME (ICG drug product), the PINPOINT Endoscopic Fluorescence Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography. The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared…

Read the full statement (178 words)

Upon intravenous administration of TRADENAME (ICG drug product), the PINPOINT Endoscopic Fluorescence Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.

The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration of TRADENAME (ICG drug product), the PINPOINT System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Indications for use as stated in the FDA summary.

Also cleared against K150956

4 other devices cite the same predicate.

  • K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc. · 2021
  • K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker · 2019
  • K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated…Stryker · 20181 recall
  • K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016

More from Novadaq Technologies Ulc. (Now A Part…

6 FDA decisions under this applicant name. See the company

  • K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
  • K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
  • K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
  • K190729SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
  • K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019

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https://510kreport.com/device/K182606 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182606: PINPOINT Endoscopic Fluorescence Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182606

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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