510(k) · Cleared
ClearedSpyglass Irrigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Scientific, Inc. · LJH System, Irrigation, Urological
Cleared on Feb 8, 2007 as substantially equivalent to K060962 (Byrne Medical, Inc., 2006) and 1 other predicate after a 57-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Feb 8, 2007
- Review
- 57 days
- Class
- Class II
- Product code
- LJH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K884836 (1988). 5 ancestors in all, the oldest K882048 (1988). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −1 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| 0 (this device) | K063700 | Spyglass Irrigation System | Medical Scientific, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1997 | 1 | 0 |
| 2006 | 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 LJH? 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 LJH device
- #1 K254111 Irrigation/Urology Setsscore 12.0 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K060962 | Endogator Endoscopy Irrigation Pump, Model Egp-100Summary page 1…erology and Urology Product Code: KOG 3. Identification of Predicate or Legally Marketed Device Endogator Endoscopy Irrigation Pump - K060962, K03 1773 4. Device Description Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pu… | 2006 |
| * | K031773 | Endo Gator SystemSummary page 1…nd Urology Product Code: KOG 3. Identification of Predicate or Legally Marketed Device Endogator Endoscopy Irrigation Pump - K060962, K03 1773 4. Device Description Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pump… | 2003 |
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 14.5 years on median.
- None of the 5 ancestors has a recall.
- 4 other devices also cite its predicate K060962.
How does its category compare?
All LJH devicesLJH System, Irrigation, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LJH
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · LJH
77in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJH
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJH
25in 2025
MAUDE reports naming product code LJH, 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 | 3 | 77 | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 30 |
| 2011 | 0 | — | 0 | 27 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 97 |
| 2015 | 0 | — | 0 | 642 |
| 2016 | 0 | — | 0 | 32 |
| 2017 | 1 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 0 | — | 1 | 21 |
| 2023 | 0 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
To provide irrigation during endoscopic surgical procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063700 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063700: Spyglass Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063700
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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