510(k) · Cleared
ClearedGabriel Ureteral Illuminator System II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gabriel Medical, Inc. · FCS Light, Catheter, Fiberoptic, Glass, Ureteral
Cleared on Feb 7, 1995 after a 113-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 40 later devices descend from it.
- Decided
- Feb 7, 1995
- Review
- 113 days
- Class
- Class II
- Product code
- FCS
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 2 citing it directly.
- This deviceK945088 Gabriel Ureteral Illuminator System IIGabriel Medical, Inc. · 1995
- Descendant · cites it directly · 36 of its ownK982542 Stryker Ureteral Illuminator System IiiStryker Endoscopy · 1998 · Recalled
- Descendant · 2 generations on · 35 of its ownK061548 Stryker Ureteral Illumination System IVStryker Corp. · 2006
- Descendant · 3 generations on · 34 of its ownK151243 STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and…Stryker Endoscopy · 2015
- Descendant · 4 generations on · 33 of its ownK182160 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688…Stryker · 2018 · Recalled
- Descendant · 5 generations on · 26 of its ownK202592 Adavanced Imaging Modality System (1688 4K Camera System With…Stryker · 2020
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K982542Stryker Ureteral Illuminator System IiiStryker Endoscopy · 1998 · cites it directly36descendants
- K061548Stryker Ureteral Illumination System IVStryker Corp. · 2006 · 2 generations on35descendants
- K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy · 2015 · 3 generations on34descendants
- K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker · 2018 · 4 generations on33descendants
- K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker · 2020 · 5 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945088 | Gabriel Ureteral Illuminator System II | Gabriel Medical, Inc. | 1995 | — |
| +1 | K982542 | Stryker Ureteral Illuminator System Iii | Stryker Endoscopy | 1998 | 1 |
| +2 | K061548 | Stryker Ureteral Illumination System IV | Stryker Corp. | 2006 | — |
| +3 | K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS… | Stryker Endoscopy | 2015 | — |
| +4 | K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K… | Stryker | 2018 | 1 |
| +5 | K202592 | Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging… | Stryker | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FCS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (40)
See all 402 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982542 (Stryker Endoscopy, 1998) has gone furthest, with 36 descendants of its own.
How does its category compare?
All FCS devicesFCS Light, Catheter, Fiberoptic, Glass, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCS
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · FCS
Too few FCS 510(k)s in any year since 2007 to give a median.
Recalls per year · FCS
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCS
3in 2025
MAUDE reports naming product code FCS, 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 | 0 |
| 2008 | 0 | — | 2 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 17 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K945088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945088: Gabriel Ureteral Illuminator System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945088
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026