510(k) · Cleared
ClearedVaporization Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Cleared on Apr 10, 1998 as substantially equivalent to K953983 (Richard Wolf Medical Instruments Corp., 1996) after a 389-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Apr 10, 1998
- Review
- 389 days
- Class
- Class II
- Product code
- KNF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953983 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK953983 Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical…Richard Wolf Medical Instruments Corp. · 1996
- This deviceK970961 Vaporization ElectrodesRichard Wolf Medical Instruments Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953983 | Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of… | Richard Wolf Medical Instruments Corp. | 1996 | — |
| 0 (this device) | K970961 | Vaporization Electrodes | Richard Wolf Medical Instruments Corp. | 1998 | — |
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 KNF? 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 KNF device
- #1 K240503 Sonata Transcervical Fibroid Ablation System 2.2score 13.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K953983 | Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft TissueSummary page 2…substantially equivalent 1o devices sold or previously sold by Richard Wolf Medical Instruments, Circon, and ProSurg. Specifically Richard Wolf models approved by 510(k) K953983, Circon model VE-B, and proSurg model SB-24W. /] =] Performance Data Devices were tested to meet the appropriate sections of th… | 1996 |
| * | — | Circon model VE-B Named without a submission number | |
| * | — | ProSurg model SB-24W Named without a submission number | |
| * | — | ACMI/Circon Named without a submission number |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K953983.
How does its category compare?
All KNF devicesKNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNF
Too few KNF 510(k)s in any year since 2007 to give a median.
Recalls per year · KNF
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNF
93in 2025
MAUDE reports naming product code KNF, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 3 | 1 |
| 2010 | 1 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 1 | 24 |
| 2014 | 1 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 1 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 0 | 93 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
These specific EVAP electrodes can be used for vaporization, ablation, coagulation, and or resection of soft tissue in the urology tract and/or fibroids or myomas. The electrodes can be used for endometrial ablation and endometriosis.
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/K970961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970961: Vaporization Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970961
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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