510(k) · Cleared
Cleared1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · GWG Endoscope, Neurological
Cleared on Aug 6, 2021 as substantially equivalent to K180146 (Karl Storz Endoscopy America, Inc., 2018) and 1 other predicate after a 106-day review. Its family tree reaches back 20 generations to 1994. 19 later devices descend from it.
- Decided
- Aug 6, 2021
- Review
- 106 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K930667 (1994). 117 ancestors in all, the oldest K811390 (1981). 19 later devices descend from it, 5 citing it directly.
- Root · 20 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 16 generations between
- 3 generations backK182160 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688…Stryker · 2018 · Recalled
- 2 generations backK202592 Adavanced Imaging Modality System (1688 4K Camera System With…Stryker · 2020
- 1 generation backK210088 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight…Stryker · 2021
- This deviceK211202 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight…Stryker · 2021
- Descendant · cites it directly · 14 of its ownK214046 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM…Stryker · 2022
- Descendant · 2 generations on · 10 of its ownK221611 780 nm L11 LED Light Source with AIMStryker · 2022
- Descendant · 2 generations on · 8 of its ownK230216 1688 4K Camera Control Unit with Advanced Imaging Modality…Stryker · 2023
- Descendant · 2 generations on · 6 of its ownK230754 L12 LED Light Source with AIMStryker · 2023
- Descendant · 2 generations on · 6 of its ownK230605 1788 4K Camera System with Advanced Imaging ModalityStryker · 2023
Show all 20 generations
- Root · 20 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 19 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 18 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 17 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 16 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 15 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 14 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 13 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 12 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 11 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 10 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 9 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- 8 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 7 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- 6 generations backK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
- 5 generations backK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
- 4 generations backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- 3 generations backK182160 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688…Stryker · 2018 · Recalled
- 2 generations backK202592 Adavanced Imaging Modality System (1688 4K Camera System With…Stryker · 2020
- 1 generation backK210088 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight…Stryker · 2021
- This deviceK211202 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight…Stryker · 2021
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker · 2022 · cites it directly14descendants
- K221611780 nm L11 LED Light Source with AIMStryker · 2022 · 2 generations on10descendants
- K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker · 2023 · 2 generations on8descendants
- K230754L12 LED Light Source with AIMStryker · 2023 · 2 generations on6descendants
- K2306051788 4K Camera System with Advanced Imaging ModalityStryker · 2023 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −19 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −18 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −17 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −16 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −15 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −14 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −13 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −12 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −11 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −10 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −9 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| −8 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| −7 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
| −6 | K141077 | DA Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2014 | 2 |
| −5 | K150956 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | 1 |
| −4 | K161792 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | — |
| −3 | K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K… | Stryker | 2018 | 1 |
| −2 | K202592 | Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging… | Stryker | 2020 | — |
| −1 | K210088 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM… | Stryker | 2021 | — |
| 0 (this device) | K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable… | Stryker | 2021 | — |
| +1 | K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and… | Stryker | 2022 | — |
| +2 | K221611 | 780 nm L11 LED Light Source with AIM | Stryker | 2022 | — |
| +2 | K230216 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) | Stryker | 2023 | — |
| +2 | K230754 | L12 LED Light Source with AIM | Stryker | 2023 | — |
| +2 | K230605 | 1788 4K Camera System with Advanced Imaging Modality | Stryker | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 11 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 GWG? 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 GWG device
- #1 K253602 Precision S 4K Sinuscopescore 17.4 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180146 | KARL STORZ ICG Imaging SystemSummary page 6…510(k) Review Ear Nose & Throat Panel: Neurology Predicate Device(s): Karl Storz ICG Imaging System K180146 (primary) AIM System: 1688 4K Camera K210088 (secondary) System, L11 LED Light Source and SafeLig… | 2018 |
| * | K210088 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Summary page 6…nel: Neurology Predicate Device(s): Karl Storz ICG Imaging System K180146 (primary) AIM System: 1688 4K Camera K210088 (secondary) System, L11 LED Light Source and SafeLight Cable NOTE: The predicate device has not been subje… | 2021 |
| † | K191102 | Precision S 4K Sinuscope | 2019 |
What descends from it? (19)
See all 195 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable | 2022 | 14 |
| K253602 | Precision S 4K Sinuscope | 2026 | 0 |
| K222130 | 1688 4K Camera System with Advanced Imaging Modality | 2022 | 0 |
| K220895 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K… | 2022 | 0 |
| K212511 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K… | 2021 | 0 |
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 27 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 30 of the 117 ancestors have a recall of any class.
- Of its descendants, K214046 (Stryker, 2022) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K180146.
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · GWG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWG
269in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWG
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWG
33in 2025
MAUDE reports naming product code GWG, 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 | 0 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 37 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 4 | 126 | 0 | 12 |
| 2018 | 4 | 128 | 0 | 16 |
| 2019 | 3 | 156 | 0 | 10 |
| 2020 | 2 | — | 0 | 19 |
| 2021 | 3 | 106 | 0 | 21 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 5 | 269 | 0 | 9 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 33 |
| 2026 | 4 | 217 | 0 | — |
What is it indicated for?
1688 4K Camera System with Advanced Imaging Modality (AIM): The 1688 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic…
Read the full statement (501 words)
1688 4K Camera System with Advanced Imaging Modality (AIM):
The 1688 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients.
A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement.
The users of the 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists.
L11 LED Light Source with Advanced Imaging Modality (AIM) and SafeLight Cable:
Upon intravenous administration of SPY AGENTTM GREEN (indocyanine green for injection, USP), the L11 LED Light Source with AIM and SafeLightTM Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visual light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
Additionally, the L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near-infrared imaging.
Upon interstitial administration of SPY AGENT GREEN, the L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
The L11 LED Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Precision S 4K Sinuscope:
The Precision S 4K Sinuscope is intended for use in otolaryngology and head and neck procedures, including rhinology, endoscopic plastic and reconstructive surgery. The Precision S 4K Sinuscope is also intended for use in minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211202: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211202
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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