510(k) · Cleared
ClearedSide Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode with Hand Controls, S90 with Hand
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 Apr 6, 2012 as substantially equivalent to K002422 (Mitek Products, 2000) and 4 other predicates after an 85-day review. Its family tree reaches back 11 generations to 1993.
- Decided
- Apr 6, 2012
- Review
- 85 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K931783 (1993). 50 ancestors in all, the oldest K852143 (1985). No later device cites it as a predicate yet.
- Root · 11 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 7 generations between
- 3 generations backK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled
- 2 generations backK083161 Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter…Conmed Linvatec · 2009
- 1 generation backK100638 Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless…Depuy Mitek, A Johnson & Johnson Company · 2010
- This deviceK120095 Side Effect with Hand Controls, Hook Electrode with Hand Controls…Depuy Mitek, A Johnson & Johnson Company · 2012
Show all 11 generations
- Root · 11 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 10 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 9 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 8 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 7 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 6 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- 5 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 4 generations backK033135 Stryker Wireless Universal Footswitch SystemStryker Endoscopy · 2004
- 3 generations backK053510 IR Wireless Foot SwitchLinemaster Switch Corp. · 2006 · Recalled
- 2 generations backK083161 Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter…Conmed Linvatec · 2009
- 1 generation backK100638 Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless…Depuy Mitek, A Johnson & Johnson Company · 2010
- This deviceK120095 Side Effect with Hand Controls, Hook Electrode with Hand Controls…Depuy Mitek, A Johnson & Johnson Company · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −10 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −9 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −8 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −7 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −6 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| −5 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| −4 | K033135 | Stryker Wireless Universal Footswitch System | Stryker Endoscopy | 2004 | — |
| −3 | K053510 | IR Wireless Foot Switch | Linemaster Switch Corp. | 2006 | 2 |
| −2 | K083161 | Zen Wireless Footswitch (W1000), Zen Wireless Footswitch Adapter (W1100) | Conmed Linvatec | 2009 | — |
| −1 | K100638 | Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| 0 (this device) | K120095 | Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge… | Depuy Mitek, A Johnson & Johnson Company | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 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? (5)
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 |
|---|---|---|---|
| * | K002422 | Varpr 3.5MM 90 Suction Electrode for Use with Vapr SystemSummary page 1…Predica te The proposed P50 Electrode with Handcontrols is substantially Device(s) equivalent to: *K002422: VAPR 90' Suction Electrode (August 31, 2000) .K082643: VAPR Electrodes with Handpieces (Decem… | 2000 |
| * | K082643 | 3.5 MM Side Effect Electrode with Integrated Handpiece, Model 227301, 3.5 MM Angled Side…Summary page 1…ly Device(s) equivalent to: *K002422: VAPR 90' Suction Electrode (August 31, 2000) .K082643: VAPR Electrodes with Handpieces (December 19, 2008) 1100638: VAPR VUE including CP9O Handcont… | 2008 |
| * | K100638 | Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Summary page 2…NK041135: VAPR LPS Electrode (May 10, 2004) 0K082643: VAPR Electrodes with Handpieces (December 19, 2008) KK100638: VAPR VUE including CP90 Handcontrol (June 18, 2010) The proposed Side Effect, Hook and Wedge Elect… | 2010 |
| * | K041135 | Vapr 3 Electrosurgical System and Vapr LD and LP Suction ElectrodesSummary page 2…R Electrodes with l-andcontrols The proposed 590 Electrode with Handcontrols issubstantially NK041135: VAPR LPS Electrode (May 10, 2004) 0K082643: VAPR Electrodes with Handpieces (December 19, 2008)… | 2004 |
| * | K963783 | Mitek Electrosurgical System for Arthroscopic UseSummary page 2…The proposed Side Effect, Hook and Wedge Electrode with Handcontrols are substantially equivalent to: * K(963783 Mitek Electrosurgical System (December 25, 1996) * K(082643 VAPR Electrode with Integrated Electrod… | 1996 |
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 19 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 50 ancestors have a recall of any class.
- 5 other devices also cite its predicate K002422.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 DePuy Mitek VAPR Electrodes for use with the VAPR System are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue 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/K120095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120095: Side Effect with Hand Controls, Hook Electrode with Hand Controls, 2.3 Wedge Electrode with Hand Controls, S90 with Hand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120095
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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