510(k) · Cleared
ClearedThe Fugo Blade for Dentistry
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisurg, Ltd. · EKZ Unit, Electrosurgical, And Accessories, Dental
Cleared on Apr 18, 2007 as substantially equivalent to K000768 (Wallach Surgical Devices, Inc., 2000) and 3 other predicates after a 153-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Apr 18, 2007
- Review
- 153 days
- Class
- Class II
- Product code
- EKZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K000768 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK000768 Wallach Quantum 500 Electrosurgical GeneratorWallach Surgical Devices, Inc. · 2000
- This deviceK063468 The Fugo Blade for DentistryMedisurg, Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000768 | Wallach Quantum 500 Electrosurgical Generator | Wallach Surgical Devices, Inc. | 2000 | — |
| 0 (this device) | K063468 | The Fugo Blade for Dentistry | Medisurg, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 EKZ? 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 EKZ device
- #1 K213477 Root ZX3score 5.3 · 6 generations · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K000768 | Wallach Quantum 500 Electrosurgical GeneratorSummary page 1…te device: (807.92(a)(3)) A) Equivalence from an intended use standpoint: FDA cleared Wallach Quantum 500 electrosurgical generator for surgery - K000768 B) Equivalence from a technologic standpoint: a. Fugo Blade for Capsulotomy - FDA ft K001498 b. Fug… | 2000 |
| * | K001498 | The Fugo BladeSummary page 1…antum 500 electrosurgical generator for surgery - K000768 B) Equivalence from a technologic standpoint: a. Fugo Blade for Capsulotomy - FDA ft K001498 b. Fugo Blade for Glaucoma-FDA ft K041019 c. Fugo Blade for Peripheral Iridotomy - FDA # K050933 Descrip… | 2000 |
| * | K041019 | The Fugo Blade for GlaucomaSummary page 1…K000768 B) Equivalence from a technologic standpoint: a. Fugo Blade for Capsulotomy - FDA ft K001498 b. Fugo Blade for Glaucoma-FDA ft K041019 c. Fugo Blade for Peripheral Iridotomy - FDA # K050933 Description of the device (807.92(a)(4)) The Fugo Blad… | 2004 |
| * | K050933 | Fugo Blade for Peripheral Iridotomy, Model M300Summary page 1…a. Fugo Blade for Capsulotomy - FDA ft K001498 b. Fugo Blade for Glaucoma-FDA ft K041019 c. Fugo Blade for Peripheral Iridotomy - FDA # K050933 Description of the device (807.92(a)(4)) The Fugo Blade for dentistry is an electrosurgical device that is powered by the… | 2005 |
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?
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All EKZ devicesEKZ Unit, Electrosurgical, And Accessories, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EKZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · EKZ
Too few EKZ 510(k)s in any year since 2007 to give a median.
Recalls per year · EKZ
No recall names EKZ since 2007.
Adverse event reports per year · EKZ
6in 2018
MAUDE reports naming product code EKZ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Excisional and incisional biopsy
Exposure of tnerupted teeth
Fibroma removal
Frenectomy and frenotomy
Gingival troughing for crown impressions
Leukoplakia
Operculectomy
Gingivoplasty (contouring of gingival tissue)
Gingivectomy (excision of unsupported gingival tissue)
Gingival incision and excision
Hemostatis
Implant recovery
Incision and drainage of abscess
Oral papillectomies
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
Reduction of gingival hypertrophy
Soft tissue crown lengthening
Treatment of aphthous ulcers
Vestibuloplasty
Biopsy incision and excision
Lesion removal
Tumor removal
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063468 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063468: The Fugo Blade for Dentistry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063468
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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