510(k) · Cleared
ClearedReprocessed Unipolar Laparoscopic/Endoscopic Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Medical Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 22, 2001 as substantially equivalent to K984240 (Ethicon Endo-Surgery, Inc., 1999) and 2 other predicates after a 70-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Oct 22, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K910831 (1991). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK910831 Endopath Surgical InstrumentsSymbiosis Corp. · 1991
- 1 generation backK984240 Endopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc. · 1999 · Recalled
- This deviceK012625 Reprocessed Unipolar Laparoscopic/Endoscopic InstrumentsAlliance Medical Corp. · 2001
- Descendant · cites it directly · 0 of its ownK240334 LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D…Lagis Enterprise Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK031869 Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments…Surgical Instruments Service and Savings, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See all- K240334LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D…Lagis Enterprise Co., Ltd. · 2024 · cites it directly0descendants
- K031869Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and AccessoriesSurgical Instruments Service and Savings, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910831 | Endopath Surgical Instruments | Symbiosis Corp. | 1991 | — |
| −1 | K984240 | Endopath Endoscopic Instruments | Ethicon Endo-Surgery, Inc. | 1999 | 1 |
| 0 (this device) | K012625 | Reprocessed Unipolar Laparoscopic/Endoscopic Instruments | Alliance Medical Corp. | 2001 | — |
| +1 | K240334 | LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D… | Lagis Enterprise Co., Ltd. | 2024 | — |
| +1 | K031869 | Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and… | Surgical Instruments Service and Savings, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K984240 | Endopath Endoscopic InstrumentsSummary page 1…icon |Endopath ® Straight Dissector DSD33 Ethicon |[Endopath ® Curved Dissector 5DCD Ethicon |Endopath ® Curved Dissector SCD32 Predicate K evice Descript device(s): K984240 |Ethicon Endopath ® Endoscopic Instrument| GEI Ethicon Endopath ® Endoscopic K934784 |Electrosurgical Forceps GEl Ethicon Endopat… | 1999 |
| * | K934784 | Endopath Endoscopic Electrosurgical Forceps with Cutting FeatureSummary page 1…D Ethicon |Endopath ® Curved Dissector SCD32 Predicate K evice Descript device(s): K984240 |Ethicon Endopath ® Endoscopic Instrument| GEI Ethicon Endopath ® Endoscopic K934784 |Electrosurgical Forceps GEl Ethicon Endopath ® Endoscopic Surgical K930933 |Instruments GCJ Alliance Medical Corporation 9 Repr… | 1994 |
| * | K930933 | Endopath Endoscopic Surgical InstrumentsSummary page 1…vice(s): K984240 |Ethicon Endopath ® Endoscopic Instrument| GEI Ethicon Endopath ® Endoscopic K934784 |Electrosurgical Forceps GEl Ethicon Endopath ® Endoscopic Surgical K930933 |Instruments GCJ Alliance Medical Corporation 9 Reprocessed Laparoscopic/Endoscopic Instruments Traditional 510(k) === Page 2… | 1993 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K240334 (Lagis Enterprise Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 12 other devices also cite its predicate K984240.
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 Unipolar Laparoscopic/Endoscopic Instruments, including scissors, dissectors, and graspers, are to be used for patients requiring minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue.
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/K012625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012625: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012625
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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