510(k) · Cleared
Recalled · 2006The Fugo Blade
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisurg, Ltd. · NCR Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
Cleared on Aug 10, 2000 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 59 later devices descend from it. It has been recalled once.
- Decided
- Aug 10, 2000
- Review
- 87 days
- Class
- Class II
- Product code
- NCR
- Recalls
- 1
- Predicates
- 0
59 later devices descend from it, 5 citing it directly.
- This deviceK001498 The Fugo BladeMedisurg, Ltd. · 2000
- Descendant · cites it directly · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- Descendant · 2 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- Descendant · 2 generations on · 31 of its ownK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- Descendant · 2 generations on · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- Descendant · 3 generations on · 19 of its ownK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · cites it directly51descendants
- K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 2 generations on47descendants
- K092647Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 2 generations on31descendants
- K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · 2 generations on30descendants
- K113151Ifs Laser SystemAbbott Medical Optics, Inc. · 2012 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001498 | The Fugo Blade | Medisurg, Ltd. | 2000 | — |
| +1 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +2 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
| +2 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +2 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| +3 | K113151 | Ifs Laser System | Abbott Medical Optics, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NCR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (59)
See all 595 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2006 | Not classified | Z-1224-06 | Other | No documentation to support shelf life/sterility |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082947 (Lensx Lasers, Inc., 2009) has gone furthest, with 51 descendants of its own.
How does its category compare?
All NCR devicesNCR Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NCR
FDA has decided no NCR device since 2007.
Median 510(k) review, days · NCR
Too few NCR 510(k)s in any year since 2007 to give a median.
Recalls per year · NCR
No recall names NCR since 2007.
Adverse event reports per year · NCR
No MAUDE report names NCR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K001498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001498: The Fugo Blade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001498
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026