510(k) · Cleared
ClearedSyntec True Light End Irrigating Endoilluminator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vaughan Weeks · MPA Endoilluminator
Cleared on Nov 18, 1997 as substantially equivalent to K884043 (Grieshaber & Co., 1988) after a 77-day review. Its family tree reaches back 1 generation to 1988. 11 later devices descend from it.
- Decided
- Nov 18, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- MPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884043 (1988). 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK884043 Grieshaber Micro Lite Light Pipe 19 & 20 GaugeGrieshaber & Co. · 1988
- This deviceK973293 Syntec True Light End Irrigating EndoilluminatorVaughan Weeks · 1997
- Descendant · cites it directly · 10 of its ownK041108 Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation · 2004
- Descendant · cites it directly · 9 of its ownK080067 Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 2008 · Recalled
- Descendant · 2 generations on · 6 of its ownK173332 OMNI Surgical SystemSight Sciences, Inc. · 2017
- Descendant · 3 generations on · 2 of its ownK202678 OMNI Surgical SystemSight Sciences, Inc. · 2021
- Descendant · 4 generations on · 1 of its ownK232214 OMNI Surgical SystemSight Sciences, Inc. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K041108Iscience Surgical Ophthalmic MicrocannulaIscience Surgical Corporation · 2004 · cites it directly10descendants
- K080067Iscience Interventional Ophthalmic MicrocatheterIscience Interventional · 2008 · cites it directly9descendants
- K173332OMNI Surgical SystemSight Sciences, Inc. · 2017 · 2 generations on6descendants
- K202678OMNI Surgical SystemSight Sciences, Inc. · 2021 · 3 generations on2descendants
- K232214OMNI Surgical SystemSight Sciences, Inc. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884043 | Grieshaber Micro Lite Light Pipe 19 & 20 Gauge | Grieshaber & Co. | 1988 | — |
| 0 (this device) | K973293 | Syntec True Light End Irrigating Endoilluminator | Vaughan Weeks | 1997 | — |
| +1 | K041108 | Iscience Surgical Ophthalmic Microcannula | Iscience Surgical Corporation | 2004 | — |
| +1 | K080067 | Iscience Interventional Ophthalmic Microcatheter | Iscience Interventional | 2008 | 2 |
| +2 | K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017 | — |
| +3 | K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021 | — |
| +4 | K232214 | OMNI Surgical System | Sight Sciences, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 MPA? 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 MPA device
- #1 K253468 Nova Eye iTrack™ 250A Canaloplasty…score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K884043 | Grieshaber Micro Lite Light Pipe 19 & 20 GaugeSummary page 1…mbers 630.02G and 631.02 20G manufactured by Grieshaber & Co. Inc. located at 1945 Vaughn Road, Kennesaw, GA 30144. This device was the subject of Premarket Notification K884043. Device Description: The End Irrigating Endoilluminator comprises of five basic components. The handpiece handle. The handpiece… | 1988 |
What descends from it? (11)
See all 112 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?
- Its one ancestor has no recall.
- Of its descendants, K041108 (Iscience Surgical Corporation, 2004) has gone furthest, with 10 descendants of its own.
How does its category compare?
All MPA devicesMPA Endoilluminator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MPA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MPA
Too few MPA 510(k)s in any year since 2007 to give a median.
Recalls per year · MPA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MPA
11in 2025
MAUDE reports naming product code MPA, 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 | 4 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 0 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 19 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 2 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 62 |
| 2025 | 0 | — | 1 | 11 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Syntec, Inc. True Light End Irrigating Endoilluminator is used to illuminate with visible.specFrum.llght the intra ocular portion of the eye for improved visualization and to provide irrigation during vitreo-retinal surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973293 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973293: Syntec True Light End Irrigating Endoilluminator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973293
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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