510(k) · Cleared
ClearedEnlightenVue Microendoscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enlightenvue, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 20, 2020 as substantially equivalent to K981928 (Galileo Electro-Optics Corp., 1998) after a 210-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Mar 20, 2020
- Review
- 210 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981928 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981928 Galileo Disposable EndoscopesGalileo Electro-Optics Corp. · 1998
- This deviceK192300 EnlightenVue Microendoscopy SystemEnlightenvue, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981928 | Galileo Disposable Endoscopes | Galileo Electro-Optics Corp. | 1998 | — |
| 0 (this device) | K192300 | EnlightenVue Microendoscopy System | Enlightenvue, Inc. | 2020 | — |
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 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 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? (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 |
|---|---|---|---|
| * | K981928 | Galileo Disposable EndoscopesSummary page 4…tenVue Microendoscopy System Common/Usual Name: Endoscope Classification Name: Endoscope 3. PREDICATE DEVICE Galileo Disposable Endoscope (K981928) 4. DEVICE DESCRIPTION The enlightenVue Microendoscopy System is comprised of the surgiVue microendoscope… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 2 other devices also cite its predicate K981928.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The enlightenVue Microendoscopy System is intended for visualization of body cavities, hollow organs, and canals. The
surgiVue microendoscope is designed to be introduced through natural body cavities or surgical incisions through
introducers, trocars, needles, sheaths, or other devices with lumens having inside diameters larger than the outer diameter
of the microendoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192300: EnlightenVue Microendoscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192300
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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