510(k) · Cleared
ClearedNeoscope - Endoscopic Diagnostic & Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prosurg, Inc. · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Feb 3, 2005 after a 120-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Feb 3, 2005
- Review
- 120 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK042780 Neoscope - Endoscopic Diagnostic & Treatment SystemProsurg, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK152619 Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)Prosurg, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K152619Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)Prosurg, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042780 | Neoscope - Endoscopic Diagnostic & Treatment System | Prosurg, Inc. | 2005 | — |
| +1 | K152619 | Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) | Prosurg, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FAJ? 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 FAJ device
- #1 K193095 Ambu aScope 4 Cystoscore 31.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K152619 | Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) | 2016 | 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?
- Of its descendants, K152619 (Prosurg, Inc., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FAJ devicesFAJ Cystoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAJ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAJ
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAJ
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAJ
2,690in 2025
MAUDE reports naming product code FAJ, 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 | 2 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 75 |
| 2017 | 2 | — | 1 | 79 |
| 2018 | 2 | — | 0 | 79 |
| 2019 | 3 | 207 | 0 | 102 |
| 2020 | 2 | — | 0 | 339 |
| 2021 | 3 | 127 | 0 | 494 |
| 2022 | 5 | 170 | 1 | 744 |
| 2023 | 5 | 207 | 7 | 920 |
| 2024 | 9 | 130 | 0 | 892 |
| 2025 | 8 | 98 | 0 | 2,690 |
| 2026 | 5 | 123 | 0 | — |
What is it indicated for?
Neoscope TM - Endoscopic Diagnostic and Treatment System is intended for cystoscopic, hysteroscopic laparoscopic, resectoscopic and endoscopic treatment of urological, gynecological, gasteroenterological disorders and diseases of prostate, bladder, urethra, uterine cavity, stomach, GI, urinary tract and reproductive organs using biomaterials, laser & RF devices, tissue ablative and augmenting agents, microsurgical instrument and endoscopic accessories.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042780 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042780: Neoscope - Endoscopic Diagnostic & Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042780
Report an extraction error
Are you the manufacturer?
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