510(k) · Cleared
ClearedNeoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prosurg, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 29, 2016 as substantially equivalent to K042780 (Prosurg, Inc., 2005) and 1 other predicate after a 228-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Apr 29, 2016
- Review
- 228 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K042780 (2005). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK042780 Neoscope - Endoscopic Diagnostic & Treatment SystemProsurg, Inc. · 2005
- This deviceK152619 Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)Prosurg, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042780 | Neoscope - Endoscopic Diagnostic & Treatment System | Prosurg, Inc. | 2005 | — |
| 0 (this device) | K152619 | Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) | Prosurg, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (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 |
|---|---|---|---|
| * | K042780 | Neoscope - Endoscopic Diagnostic & Treatment SystemSummary page 4…urer: Trade Name: 510K # to which the substantially Equivalency is claimed Prosurg, Inc NeoScopeTM -Endoscopic K042780 Diagnostic & Treatment System… | 2005 |
| * | K120766 | Endoscopic Diagnostic & Treatment System (Modification)Summary page 4…Diagnostic & Treatment System Prosurg, Inc NeoscopeTM –Digital K120766 Video Endoscopy System… | 2012 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Prosurg’s Neoscope 3D™ -3D Digital Video Endoscopic System ( Rigid & Flexible) is intended to provide “Real -Time” 3D images and video to surgeons for endoscopic examination, diagnosis and treatment for Minimally Invasive surgical Procedures within Abdominal and Female Reproductive organs, using surgical devices and accessories.
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/K152619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152619: Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152619
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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