510(k) · Cleared
ClearedSyntec True Light Endoillumiinator with Pick
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vaughan Weeks · MPA Endoilluminator
Cleared on Nov 14, 1997 as substantially equivalent to K875004 (Advanced Surgical Products, Inc., 1988) after a 73-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.
- Decided
- Nov 14, 1997
- Review
- 73 days
- Class
- Class II
- Product code
- MPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K875004 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK875004 Prisma Dispos. Brite Lite Fiberoptic Endo. W/PickAdvanced Surgical Products, Inc. · 1988
- This deviceK973290 Syntec True Light Endoillumiinator with PickVaughan Weeks · 1997
- Descendant · cites it directly · 0 of its ownK202670 Nam illumination probe with chopperOculight, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K202670Nam illumination probe with chopperOculight, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K875004 | Prisma Dispos. Brite Lite Fiberoptic Endo. W/Pick | Advanced Surgical Products, Inc. | 1988 | — |
| 0 (this device) | K973290 | Syntec True Light Endoillumiinator with Pick | Vaughan Weeks | 1997 | — |
| +1 | K202670 | Nam illumination probe with chopper | Oculight, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 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? (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 |
|---|---|---|---|
| * | K875004 | Prisma Dispos. Brite Lite Fiberoptic Endo. W/PickSummary page 1…rs 630.06 20G and 631.06 20G manufactured by Grieshaber & Co. Inc. located at 1945 Vaughn Road, Kennesaw, GA 30144. This device was the subject of Premarket Notification K875004. Gamp & Associates Disposable Fiberoptic Endoilluminator with Pick. 16818 Kingstowne Way Drive, Ballwin, MO 63011. Device Desc… | 1988 |
| * | — | Gamp & Associates Disposable Fiberoptic Endoilluminator with Pick Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202670 | Nam illumination probe with chopper | 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?
- Its one ancestor has no recall.
- Of its descendants, K202670 (Oculight, Ltd., 2021) has gone furthest, with 0 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 Endoilluminator with Pick is used to illuminate with visible spectrum light the intra ocular portion of the eye for improved visualization and manipulation 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/K973290 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973290: Syntec True Light Endoillumiinator with Pick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973290
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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