510(k) · Cleared
Recalled · Class II · 20123.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM Angled Side Effect Electrode with Integrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 19, 2008 as substantially equivalent to K041135 (Depuy Mitek, A Johnson & Johnson Company, 2004) and 6 other predicates after a 99-day review. Its family tree reaches back 3 generations to 1996. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 19, 2008
- Review
- 99 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 7
Its longest line of descent runs back 3 generations to K963783 (1996). 8 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK963783 Mitek Electrosurgical System for Arthroscopic UseETHICON, Inc. · 1996
- 2 generations backK992876 Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemMitek Products · 1999
- 1 generation backK041135 Vapr 3 Electrosurgical System and Vapr LD and LP Suction ElectrodesDepuy Mitek, A Johnson & Johnson Company · 2004
- This deviceK082643 3.5 MM Side Effect Electrode with Integrated Handpiece, Model…Depuy Mitek, A Johnson & Johnson Company · 2008
- Descendant · cites it directly · 8 of its ownK100638 Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless…Depuy Mitek, A Johnson & Johnson Company · 2010
- Descendant · 2 generations on · 3 of its ownK152777 Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · Recalled
- Descendant · 3 generations on · 2 of its ownK161558 Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and…Bovie Medical Corporation · 2016 · Recalled
- Descendant · 3 generations on · 1 of its ownK231126 Eblator DeviceE Surgical, LLC · 2023
- Descendant · 4 generations on · 0 of its ownK251899 E BlatorNew Deantronics Taiwan, Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K100638Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Depuy Mitek, A Johnson & Johnson Company · 2010 · cites it directly8descendants
- K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation · 2016 · 2 generations on3descendants
- K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm…Bovie Medical Corporation · 2016 · 3 generations on2descendants
- K231126Eblator DeviceE Surgical, LLC · 2023 · 3 generations on1descendant
- K251899E BlatorNew Deantronics Taiwan, Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963783 | Mitek Electrosurgical System for Arthroscopic Use | ETHICON, Inc. | 1996 | — |
| −2 | K992876 | Vapr 2.3 MM Side Effect Electrode for Use with Vapr System | Mitek Products | 1999 | — |
| −1 | K041135 | Vapr 3 Electrosurgical System and Vapr LD and LP Suction Electrodes | Depuy Mitek, A Johnson & Johnson Company | 2004 | — |
| 0 (this device) | K082643 | 3.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM… | Depuy Mitek, A Johnson & Johnson Company | 2008 | — |
| +1 | K100638 | Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| +2 | K152777 | Bovie Disposable Bipolar Ablator | Bovie Medical Corporation | 2016 | 2 |
| +3 | K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating… | Bovie Medical Corporation | 2016 | 3 |
| +3 | K231126 | Eblator Device | E Surgical, LLC | 2023 | — |
| +4 | K251899 | E Blator | New Deantronics Taiwan, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (7)
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 |
|---|---|---|---|
| * | K041135 | Vapr 3 Electrosurgical System and Vapr LD and LP Suction ElectrodesSummary page 2…Substantial Equivalence The VAPR S°9 Electrode is substantially equivalent to the VAPR LPS (Low Profile Suction) Electrode (K041135, 05/10/2004). The VAPR 3.5 mm Side effect Electrode with Integrated Handpiece… | 2004 |
| * | K963783 | Mitek Electrosurgical System for Arthroscopic UseSummary page 2…The VAPR 3.5 mm Side effect Electrode with Integrated Handpiece is substantially equivalent to the Side Effect Electrode (K963783, 09/19/1996 & K974022, 01/12/1998). The VAPR 3.5 mm Hook El… | 1996 |
| * | K974022 | VAPRSummary page 2…Integrated Handpiece is substantially equivalent to the Side Effect Electrode (K963783, 09/19/1996 & K974022, 01/12/1998). The VAPR 3.5 mm Hook Electrode with Integrated Handpiece is… | 1998 |
| * | K000936 | Vapr 2.3MM Wedge Electrode for Use with Vapr SystemSummary page 2…The VAPR 2.3 mm Wedge Electrode with Integrated Handpiece is substantially equivalent to the 2.3mm Wedge Electrode (K000936, 04/19/2000). The VAPR 2.3 mm Wedge Electrode (Short) with… | 2000 |
| * | K992876 | Vapr 2.3 MM Side Effect Electrode for Use with Vapr SystemSummary page 2…egrated Handpiece, 85 mm is substantially equivalent to the 2.3 VAPR Side Effect Electrode (Short) (K992876, 09/24/1999). The VAPR 2.3 End Effect Electrode with Integrated Handpiece,… | 1999 |
| * | K992406 | Vapr 2.3MM End Effect Electrode for Use with Vapr SystemSummary page 3…Confidential VAPR Electrode with Integrated Handpiece 132 Electrode (K992406, 08/06/1999). The VAPR Temperature Control (TC) End Effect Electrode with… | 1999 |
| * | K002402 | Vapr TC Electrode for Use with Vapr II Electrosurgical SystemSummary page 3…trol (TC) End Effect Electrode with Integrated Handpiece, 2.3 mm x 140 mm is the VAPR TC Electrode (K002402, 08/31/2000). Device Classification Electrosurgical cutting and coagulating device and accessories have… | 2000 |
What descends from it? (9)
3 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 |
|---|---|---|---|---|
| Mar 12, 2012 | Class II | Z-0133-2013 | Error in labeling | Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode |
| Jun 7, 2010 | Not classified | Z-2301-2010 | Packaging process control | Product does not meet the required packaging specifications for pouch seal integrity which could lead to a breach in sterility |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K100638 (Depuy Mitek, A Johnson & Johnson Company, 2010) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K041135.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9° and S° ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle…
Read the full statement (107 words)
The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S9° and S° ) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
The VAPR TC Electrode with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, is intended for coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082643: 3.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM Angled Side Effect Electrode with Integrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082643
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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