510(k) · Cleared
ClearedGalileo Disposable Endoscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galileo Electro-Optics Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Aug 6, 1998 after a 65-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Aug 6, 1998
- Review
- 65 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK981928 Galileo Disposable EndoscopesGalileo Electro-Optics Corp. · 1998
- Descendant · cites it directly · 2 of its ownK991377 Omnisonics Flexible Fiber Optic Endoscope and CouplerOmnisonics Medical Technologies · 1999
- Descendant · cites it directly · 0 of its ownK192300 EnlightenVue Microendoscopy SystemEnlightenvue, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK080780 Anchorage Scope, Model 000003Epitek, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK993445 Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies · 1999
- Descendant · cites it directly · 0 of its ownK982630 Medworks Visualization Insemination CatheterMedworks Corp. · 1999
Most influential descendants
Showing 5 of 5 · See all- K991377Omnisonics Flexible Fiber Optic Endoscope and CouplerOmnisonics Medical Technologies · 1999 · cites it directly2descendants
- K192300EnlightenVue Microendoscopy SystemEnlightenvue, Inc. · 2020 · cites it directly0descendants
- K080780Anchorage Scope, Model 000003Epitek, Inc. · 2008 · 2 generations on0descendants
- K993445Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies · 1999 · 2 generations on0descendants
- K982630Medworks Visualization Insemination CatheterMedworks Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981928 | Galileo Disposable Endoscopes | Galileo Electro-Optics Corp. | 1998 | — |
| +1 | K991377 | Omnisonics Flexible Fiber Optic Endoscope and Coupler | Omnisonics Medical Technologies | 1999 | — |
| +1 | K192300 | EnlightenVue Microendoscopy System | Enlightenvue, Inc. | 2020 | — |
| +2 | K080780 | Anchorage Scope, Model 000003 | Epitek, Inc. | 2008 | — |
| +2 | K993445 | Omnisonic Endoscopic Deflector | Omnisonics Medical Technologies | 1999 | — |
| +1 | K982630 | Medworks Visualization Insemination Catheter | Medworks Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2008 | 1 | 0 |
| 2020 | 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 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? (8)
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 |
|---|---|---|---|
| * | — | Imagyn Laparoscope Named without a submission number | |
| * | — | Optimed Rigid Fiber Optic Endoscope Named without a submission number | |
| * | — | Model 2010 Rigid Fiber Optic Sinuscope Named without a submission number | |
| * | — | Model 4200 Fiber Optic Laparoscope Named without a submission number | |
| * | — | Fiber Optic Choledoscope Named without a submission number | |
| * | — | Rigid Sinuscope Named without a submission number | |
| * | — | Hopkins Laparoscopes Named without a submission number | |
| * | — | Hopkins Thoracoscope Named without a submission number |
What descends from it? (5)
3 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, K991377 (Omnisonics Medical Technologies, 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Galileo Disposable Endoscopes are endoscopes intended for visualization of body cavities, hollow organs, and canals. The Galileo Disposable Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope.
The indications include choledoscopy, cystoscopy, ureteroscopy, bronchoscopy, thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, general laparoscopy and urological applications.
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/K981928 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981928: Galileo Disposable Endoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981928
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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