510(k) · Cleared
ClearedCut-Vac Lighted Smoke Evacuation Electrosurgical Pencil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Surgical, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 21, 2017 as substantially equivalent to K141587 (Megadyne Medical Products, Inc., 2015) after a 43-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Apr 21, 2017
- Review
- 43 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961616 (1996). No later device cites it as a predicate yet.
- Root · 2 generations backK961616 Telescoping Penevac (Modification)I.C Medical, Inc. · 1996
- 1 generation backK141587 E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle…Megadyne Medical Products, Inc. · 2015
- This deviceK170721 Cut-Vac Lighted Smoke Evacuation Electrosurgical PencilPrecision Surgical, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961616 | Telescoping Penevac (Modification) | I.C Medical, Inc. | 1996 | — |
| −1 | K141587 | E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle Extention, Ulpa… | Megadyne Medical Products, Inc. | 2015 | — |
| 0 (this device) | K170721 | Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil | Precision Surgical, LLC | 2017 | — |
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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 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? (1)
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 |
|---|---|---|---|
| * | K141587 | E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle Extention, Ulpa Filter…Summary page 5…gulation & Accessories Device Class: Class II Classification Panel: General & Plastic Surgery 5. Legally Marketed Predicate Device(s) K141587 Zip-Pen Smoke Evacuation Electrosurgical Pencil, Megadyne Medical Products, Inc. The Zip Pen Smoke Evacuation Pencil is… | 2015 |
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 21 years and passes through 3 companies; a new generation was cleared every 18.7 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K141587.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Cut-Vac® Smoke Evacuation Electrosurgical Pencil is a monopolar device designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgical current when used in conjunction with an effective smoke evacuation system. This device conducts an electrosurgical current from an electrosurgical generator and delivers it to the target tissue to achieve the desired surgical effect.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170721: Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170721
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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