510(k) · Cleared
ClearedReprocessed DePuy Mitek Ablation Wand
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovo, Inc. · NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Cleared on Mar 19, 2018 as substantially equivalent to K113545 (Depuy Mitek, A Johnson & Johnson Company, 2012) and 2 other predicates after a 102-day review. Its family tree reaches back 11 generations to 1993.
- Decided
- Mar 19, 2018
- Review
- 102 days
- Class
- Class II
- Product code
- NUJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K931783 (1993). 67 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 deviceK173740 Reprocessed DePuy Mitek Ablation WandRenovo, Inc. · 2018
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 deviceK173740 Reprocessed DePuy Mitek Ablation WandRenovo, Inc. · 2018
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) | K173740 | Reprocessed DePuy Mitek Ablation Wand | Renovo, Inc. | 2018 | — |
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 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 2 | 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 NUJ? 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 NUJ device
- #1 K220411 Reprocessed LigaSure Curved, Small Jaw, Open…score 8.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K113545 | Vapr Vue Generator, Vapr 3 Electrosurgical System, Vapr II Electrosurgical System…Summary page 4…Name OEM 510(k) Picture Number Diameter K113545 228146 VAPR COOLPULSE 90 3.3mm K100638 VAPR COOL… | 2012 |
| * | K100638 | Vapr Vue Radiofrequency System ,Model 225024, VPR Vue Wireless Footswitch, Model 227214Summary page 4…Diameter K113545 228146 VAPR COOLPULSE 90 3.3mm K100638 VAPR COOLPULSE 90 K113545 228147 3.3mm (w/… | 2010 |
| * | K122425 | Vapr P50 Suction Electrode Vapr S90 Suction Electrode Vapr P50 Suction Electrode with…Summary page 4…K113545 228504 3.0mm HC) K100638 225370 VAPR S90 4.0mm K122425 228370 VAPR S90 (w/ HC) 4.0mm K122425 225361 LPS (2-Piece Electrode) 4.0mm K113545… | 2012 |
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 25 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 11 of the 67 ancestors have a recall of any class.
- 3 other devices also cite its predicate K113545.
How does its category compare?
All NUJ devicesNUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NUJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NUJ
88in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUJ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NUJ
38in 2025
MAUDE reports naming product code NUJ, 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 | 0 | — | 0 | 4 |
| 2008 | 1 | — | 2 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 39 |
| 2013 | 2 | — | 0 | 161 |
| 2014 | 1 | — | 0 | 74 |
| 2015 | 2 | — | 0 | 25 |
| 2016 | 5 | 155 | 0 | 52 |
| 2017 | 3 | 49 | 0 | 51 |
| 2018 | 7 | 88 | 0 | 14 |
| 2019 | 1 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 59 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 2 | — | 0 | 31 |
| 2023 | 1 | — | 3 | 27 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 0 | — | 11 | 38 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Reprocessed DePuy Mitek Ablation Wands for use with the VAPR Electrosurgical System are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173740 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173740: Reprocessed DePuy Mitek Ablation Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173740
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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