510(k) · Cleared
Recalled · Class II · 2025Reprocessed Electrosurgical Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instruments Service and Savings, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 27, 2002 after a 318-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Jun 27, 2002
- Review
- 318 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 5
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK012669 Reprocessed Electrosurgical ElectrodesSurgical Instruments Service and Savings, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK100543 Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss · 2010 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K100543Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01Medisiss · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012669 | Reprocessed Electrosurgical Electrodes | Surgical Instruments Service and Savings, Inc. | 2002 | — |
| +1 | K100543 | Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01 | Medisiss | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (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 |
|---|---|---|---|
| * | — | Same product as provided by the original manufacturer Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100543 | Medississ Reprocessedent Ablation Wands (Coblators), Model#EIC8872-01 | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2025 | Class II | Z-1547-2025 | Under Investigation by firm | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. |
| Mar 5, 2025 | Class II | Z-1546-2025 | Under Investigation by firm | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. |
| Mar 5, 2025 | Class II | Z-1549-2025 | Under Investigation by firm | Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension. |
| May 3, 2013 | Class II | Z-1628-2013 | Packaging process control | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| May 3, 2013 | Class II | Z-1644-2013 | Packaging process control | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100543 (Medisiss, 2010) has gone furthest, with 0 descendants of its own.
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?
Reprocessed electrosurgical electrodes are intended to remove tissue and control bleeding during surgery by use of electrical current.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K012669 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012669: Reprocessed Electrosurgical Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012669
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026