510(k) · Cleared
ClearedBiopolar Button Electrode, WL 150MM, W/Suction Applicator/WL 280MM, W/Suction Applicator (8801.451
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 26, 1997 as substantially equivalent to K945805 (Wells Johnson Co., 1994) after an 85-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Nov 26, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945805 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK945805 Wells Johnson Weco Monopolar/Frazier Suction ProbeWells Johnson Co. · 1994
- This deviceK973295 Biopolar Button Electrode, WL 150MM, W/Suction Applicator/WL 280MM…Richard Wolf Medical Instruments Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945805 | Wells Johnson Weco Monopolar/Frazier Suction Probe | Wells Johnson Co. | 1994 | — |
| 0 (this device) | K973295 | Biopolar Button Electrode, WL 150MM, W/Suction Applicator/WL 280MM, W/Suction… | Richard Wolf Medical Instruments Corp. | 1997 | — |
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? (1)
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 |
|---|---|---|---|
| * | K945805 | Wells Johnson Weco Monopolar/Frazier Suction ProbeSummary page 1…ion name: General and Plastic Surgery Information on devices to which substantial equivalence is claimed: S10(K) Number Trade or proprictary or model name Manufacturcr I K945805 I Monopolar/Frazier Suction Probc 1 Waells Endoscopic 2 2 2 3 3 3 4 4 3 1.0 Description The Richard Wolf Bipolar Button Electrode… | 1994 |
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.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Richard Wolf Bipolar Button Electrode with Suction Applicator is designed for use in plastic and reconstructive surgery. The device provides a method of coagulating small blood vessels that bleed as a result of blunt dissection of tissue subcutaneously. When used in conjunction with the suction applicator, smoke caused by the cauterization of tissue is evacuated from the operative site.
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/K973295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973295: Biopolar Button Electrode, WL 150MM, W/Suction Applicator/WL 280MM, W/Suction Applicator (8801.451.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973295
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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