510(k) · Cleared
Recalled · Class II · 2019Habib EUS RFA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emcision, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 7, 2016 as substantially equivalent to K150029 (Emcision, Ltd., 2015) after a 58-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jul 7, 2016
- Review
- 58 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945531 (1995). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK945531 Blade ElectrodeE & M Engineering, Inc. · 1995
- 3 generations backK994075 Geiger Disposable Electrosurgical Electrode, Model 435Geiger Medical Technologies, Inc. · 1999
- 2 generations backK123061 Ace Monopolar AttachmentBioeconeer, Inc. · 2013
- 1 generation backK150029 Habib EUS RFAEmcision, Ltd. · 2015
- This deviceK161305 Habib EUS RFAEmcision, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK170990 Active Needle Endoscopic Treatment (ANET) Electrosurgical ApplicatorSpiration, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K170990Active Needle Endoscopic Treatment (ANET) Electrosurgical ApplicatorSpiration, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945531 | Blade Electrode | E & M Engineering, Inc. | 1995 | — |
| −3 | K994075 | Geiger Disposable Electrosurgical Electrode, Model 435 | Geiger Medical Technologies, Inc. | 1999 | — |
| −2 | K123061 | Ace Monopolar Attachment | Bioeconeer, Inc. | 2013 | — |
| −1 | K150029 | Habib EUS RFA | Emcision, Ltd. | 2015 | — |
| 0 (this device) | K161305 | Habib EUS RFA | Emcision, Ltd. | 2016 | — |
| +1 | K170990 | Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator | Spiration, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K150029 | Habib EUS RFASummary page 4…JOS, GEl 6. Identification of the Predicate Predicate Device Name HABIB EUS RF A 6700 510(k) Number K150029 7. Intended use of the Subject Device The HABIB EU S RF A 6700 is indicated for coagulation and ablation of soft tis… | 2015 |
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 |
|---|---|---|---|
| K170990 | Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2019 | Class II | Z-0667-2020 | Device Design | During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the… |
| Nov 18, 2019 | Class II | Z-0668-2020 | Device Design | During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K170990 (Spiration, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K150029.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Habib EUS RFA 6700 is indicated for coagulation and ablation of soft tissue when used in conjunction with
compatible radio frequency generator.
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/K161305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161305: Habib EUS RFA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161305
Report an extraction error
Are you the manufacturer?
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