510(k) · Cleared
Recalled · 2011Suction Irrigation Electrodes and Adapters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encision, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 9, 2010 as substantially equivalent to K912780 (Electroscope, Inc., 1991) and 4 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Jun 9, 2010
- Review
- 89 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 5
- Predicates
- 5
Its longest line of descent runs back 2 generations to K934094 (1994). 7 ancestors in all, the oldest K912780 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK934094 Stryker Laparoscopic Suction IrrigatorStryker Corp. · 1994 · Recalled
- 1 generation backK963765 Stryker Strykeflow Electrocautery ProbesStryker Endoscopy · 1997 · Recalled
- This deviceK100711 Suction Irrigation Electrodes and AdaptersEncision, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK131949 Aem Disposable Suction Irrigation ElectrodesEncision, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131949Aem Disposable Suction Irrigation ElectrodesEncision, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934094 | Stryker Laparoscopic Suction Irrigator | Stryker Corp. | 1994 | 3 |
| −1 | K963765 | Stryker Strykeflow Electrocautery Probes | Stryker Endoscopy | 1997 | 1 |
| 0 (this device) | K100711 | Suction Irrigation Electrodes and Adapters | Encision, Inc. | 2010 | — |
| +1 | K131949 | Aem Disposable Suction Irrigation Electrodes | Encision, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (5)
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 |
|---|---|---|---|
| * | K912780 | Monopolar Laparoscopic Electrodes W/EletroshieldSummary page 1…Manufacturer 51 0(k) Model ES IOOO series Monopolar Laparoscopic Electroscope, Inc. (now K912780 Electrodes with Electroshield Encision Inc.) Nezhat-Dorseym Reusable Electrosurgical Davol Inc.… | 1991 |
| * | K003674 | Nezhat-Dorsey Reusable Electrosurgical Attachments: J-Hook Tip, L-Hook Tip, Corbitt…Summary page 1…80 Electrodes with Electroshield Encision Inc.) Nezhat-Dorseym Reusable Electrosurgical Davol Inc. K003674 Attachments ______________ StrykeFlow Electrocautery Probes Stryker En… | 2000 |
| * | K963765 | Stryker Strykeflow Electrocautery ProbesSummary page 1…Attachments ______________ StrykeFlow Electrocautery Probes Stryker Endoscopy K963 765 Opti4 Laparoscopic Handset and Hollow Covidien (was Valleylab K964 175 Electrodes… | 1997 |
| * | K964175 | Valleylab E2750 Laparoscopic Handset, Valleylab E2770 Series ElectrodesSummary page 1…Stryker Endoscopy K963 765 Opti4 Laparoscopic Handset and Hollow Covidien (was Valleylab K964 175 Electrodes Inc.) ____ Universal Plus Multi… | 1996 |
| * | K973890 | Universalplus Laparoscopic Abc/Electrosurgical ElectrodeSummary page 1…Inc.) ____ Universal Plus Multifunction Instrument ConMed Corp. K973890 Control Handles and Laparoscopic Electrodes with Suction Irrigation Lumen _ _ _ _ _ _ _ _… | 1998 |
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 |
|---|---|---|---|
| K131949 | Aem Disposable Suction Irrigation Electrodes | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2011 | Not classified | Z-3095-2011 | Device Design | Electrode tips have been reported breaking off during use or cleaning. |
| Aug 24, 2011 | Not classified | Z-3094-2011 | Device Design | Electrode tips have been reported breaking off during use or cleaning. |
| Aug 24, 2011 | Not classified | Z-3096-2011 | Device Design | Electrode tips have been reported breaking off during use or cleaning. |
| Aug 24, 2011 | Not classified | Z-3097-2011 | Device Design | Electrode tips have been reported breaking off during use or cleaning. |
| Aug 24, 2011 | Not classified | Z-3093-2011 | Device Design | Electrode tips have been reported breaking off during use or cleaning. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 13.4 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K131949 (Encision, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K912780.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Encision's Suction Irrigation Electrodes and Adapters are intended for evacuation of body fluids and to cut and coagulate tissue through a trocar cannula for various general surgical laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100711: Suction Irrigation Electrodes and Adapters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100711
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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