510(k) · Cleared
ClearedEvap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft Tissue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FAS Electrode, Electrosurgical, Active, Urological
Cleared on Oct 2, 1996 after a 406-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 21 later devices descend from it.
- Decided
- Oct 2, 1996
- Review
- 406 days
- Class
- Class II
- Product code
- FAS
- Recalls
- None
- Predicates
- 1
21 later devices descend from it, 2 citing it directly.
- This deviceK953983 Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical…Richard Wolf Medical Instruments Corp. · 1996
- Descendant · cites it directly · 19 of its ownK980302 Working Elements, Resectoscope Sheaths, Electrodes, Obturators…Richard Wolf Medical Instruments Corp. · 1998 · Recalled
- Descendant · 2 generations on · 12 of its ownK011496 Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators…Richard Wolf Medical Instruments Corp. · 2001
- Descendant · 3 generations on · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
- Descendant · 4 generations on · 9 of its ownK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
- Descendant · 5 generations on · 7 of its ownK160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800)…Mauna Kea Technologies · 2016
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K980302Working Elements, Resectoscope Sheaths, Electrodes, Obturators, EndoscopesRichard Wolf Medical Instruments Corp. · 1998 · cites it directly19descendants
- K011496Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and…Richard Wolf Medical Instruments Corp. · 2001 · 2 generations on12descendants
- K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · 3 generations on10descendants
- K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014 · 4 generations on9descendants
- K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies · 2016 · 5 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953983 | Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of… | Richard Wolf Medical Instruments Corp. | 1996 | — |
| +1 | K980302 | Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes | Richard Wolf Medical Instruments Corp. | 1998 | 1 |
| +2 | K011496 | Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts… | Richard Wolf Medical Instruments Corp. | 2001 | — |
| +3 | K132389 | Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes… | Daniel & Daniel Consulting | 2014 | — |
| +4 | K141358 | Cellvizio 100 Series with System Confocal Miniprobes | Mauna Kea Technologies | 2014 | — |
| +5 | K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal… | Mauna Kea Technologies | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 FAS? 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 FAS device
- #1 K250522 Multi4 Systemscore 11.4 · 7 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K946377 | FDA’s K946377 is Electroprobe Single Use Electrosurgical Probes Our OCR of the scanned summary read K946377, FDA’s number for Electroprobe Single Use Electrosurgical Probes (Ximed Medical Systems). Its FDA name has none of the distinctive words the summary uses for the device it names, “Electrodes sold by ProSurg”. Kept off the family tree. Summary page 1…(EVAP) electrode 4.0 Equivalence: The EVAP electrodes are substantially equivalent to electrodes currently sold by Richard Wolf, as well as electrodes sold by ProSurg (k946377) and ACMI/Circon (no 510(k) available). - 5.0 Description: The EVAP electrode is an electrosurgical device made of medical grad… | 1995 |
| * | — | Electrodes currently sold by Richard Wolf Named without a submission number | |
| * | — | Electrodes sold by ACMI/Circon Named without a submission number |
What descends from it? (21)
See all 212 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K980302 (Richard Wolf Medical Instruments Corp., 1998) has gone furthest, with 19 descendants of its own.
How does its category compare?
All FAS devicesFAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAS
150in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAS
395in 2025
MAUDE reports naming product code FAS, 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 | 6 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 3 | 150 | 0 | 25 |
| 2011 | 1 | — | 0 | 33 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 48 |
| 2014 | 0 | — | 0 | 52 |
| 2015 | 1 | — | 0 | 82 |
| 2016 | 1 | — | 2 | 69 |
| 2017 | 2 | — | 0 | 121 |
| 2018 | 0 | — | 0 | 70 |
| 2019 | 0 | — | 0 | 61 |
| 2020 | 0 | — | 0 | 100 |
| 2021 | 2 | — | 4 | 102 |
| 2022 | 1 | — | 0 | 147 |
| 2023 | 0 | — | 1 | 329 |
| 2024 | 1 | — | 0 | 310 |
| 2025 | 2 | — | 0 | 395 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EVAP roller electrodes can be used for removing/vaporization/ablation of soft tissue. For example; on the prostate or on myomas. The electrodes may also be used for coagulation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K953983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953983: Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft Tissue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953983
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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