510(k) · Cleared
ClearedCook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent Activation Switch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Vascular, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 15, 2003 as substantially equivalent to K021519 (Arthrocare Corp., 2002) after an 86-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Oct 15, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011083 (2001). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 3 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 2 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 1 generation backK021519 Arthrocare Controller, Authrocare Cable, Foot Control, Power Cord…Arthrocare Corp. · 2002
- This deviceK032223 Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic…Cook Vascular, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −3 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −2 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −1 | K021519 | Arthrocare Controller, Authrocare Cable, Foot Control, Power Cord, Wands | Arthrocare Corp. | 2002 | — |
| 0 (this device) | K032223 | Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic… | Cook Vascular, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 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 |
|---|---|---|---|
| * | K021519 | Arthrocare Controller, Authrocare Cable, Foot Control, Power Cord, Wands | 2002 |
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 2 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Cook Vascular PERFECTATMEDS Ergonomic Intermittent Activation Switch is an accessory to the Cook Vascular PERFECTATM Electrosurgical Dissection System. The intended use of the Cook Vascular PERFECTATMEDS Ergonomic Intermittent Activation Switch is to add the option of continuous or intermittent activation to the Electrosurgical Dissection System when the footswitch is depressed. The Cook Vascular PERFECTATMEDS Ergonomic Intermittent Activation Switch is supplied non-sterile and is reusable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032223: Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent Activation Switch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032223
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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