510(k) · Cleared
ClearedCodman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 27, 2018 as substantially equivalent to K033499 (Valley Forge Scientific Corp., 2003) after a 56-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Nov 27, 2018
- Review
- 56 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K854413 (1985). No later device cites it as a predicate yet.
- Root · 2 generations backK854413 Malis Irrigation SystemValley Forge Scientific Corp. · 1985
- 1 generation backK033499 Malis Irrigation Module 1000Valley Forge Scientific Corp. · 2003
- This deviceK182801 Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator…Integra LifeSciences Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854413 | Malis Irrigation System | Valley Forge Scientific Corp. | 1985 | — |
| −1 | K033499 | Malis Irrigation Module 1000 | Valley Forge Scientific Corp. | 2003 | — |
| 0 (this device) | K182801 | Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator… | Integra LifeSciences Corporation | 2018 | — |
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 |
|---|---|---|---|
| * | K033499 | Malis Irrigation Module 1000Summary page 4…ew Panel General & Plastic Surgery III. Predicate The predicate device for this submission is the MalisTM Irrigation Device Module 1000 (K033499), which was cleared on November 28, 2003. IV. Device The Codman Electrosurgical Irrigator is a reusable, non-sterile… | 2003 |
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 33 years and passes through 2 companies; a new generation was cleared every 18.0 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K033499.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
The Codman Electrosurgical Irrigator is indicated to provide flow of irrigation fluid to the tips of bipolar irrigating forceps during electrosurgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182801 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182801: Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182801
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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