510(k) · Cleared
ClearedMinisite*Bipolar Forceps** Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 19, 1997 as substantially equivalent to K912544 (Everest Medical Corp., 1991) after an 84-day review. Its family tree reaches back 1 generation to 1991. 1 of the 257 devices in its family, counting itself, has a Class I recall. 255 later devices descend from it.
- Decided
- Sep 19, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912544 (1991). 255 later devices descend from it, 3 citing it directly. 1 of the 257 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK912544 Bipolar ForcepsEverest Medical Corp. · 1991
- This deviceK972415 Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997
- Descendant · cites it directly · 234 of its ownK991859 Dexide Bipolar Forceps II ** DeviceUnited States Surgical, A Division of Tyco Healthc · 1999
- Descendant · 2 generations on · 233 of its ownK012833 Intuitive Surgical Bipolar ForcepsIntuitive Surgical, Inc. · 2001 · Recalled
- Descendant · 3 generations on · 229 of its ownK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- Descendant · 3 generations on · 228 of its ownK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- Descendant · 4 generations on · 224 of its ownK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
Showing 5 of 255 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223095 Senhance Surgical System5 generations on · 2023
Most influential descendants
Showing 5 of 255 · See all- K991859Dexide Bipolar Forceps II ** DeviceUnited States Surgical, A Division of Tyco Healthc · 1999 · cites it directly234descendants
- K012833Intuitive Surgical Bipolar ForcepsIntuitive Surgical, Inc. · 2001 · 2 generations on233descendants
- K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · 3 generations on229descendants
- K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · 3 generations on228descendants
- K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · 4 generations on224descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912544 | Bipolar Forceps | Everest Medical Corp. | 1991 | — |
| 0 (this device) | K972415 | Minisite*Bipolar Forceps** Device | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| +1 | K991859 | Dexide Bipolar Forceps II ** Device | United States Surgical, A Division of Tyco Healthc | 1999 | — |
| +2 | K012833 | Intuitive Surgical Bipolar Forceps | Intuitive Surgical, Inc. | 2001 | 4 |
| +3 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| +3 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| +4 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 11 | 0 |
| 2017 | 14 | 0 |
| 2018 | 18 | 0 |
| 2019 | 9 | 0 |
| 2020 | 17 | 0 |
| 2021 | 18 | 0 |
| 2022 | 18 | 0 |
| 2023 | 22 | 1 |
| 2024 | 22 | 0 |
| 2025 | 33 | 0 |
| 2026 | 23 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K912544 | Bipolar ForcepsSummary page 1…Mazzoni June 26, 1997 Electrosurgical cutting and coagulation device and accessories Bipolar Forceps Trademark name not yet determined Everest Medical BiCOAG Forceps (K912544) The Minisite* Bipolar Forceps** Device is a laparoscopic coagulating forceps device that is intended to be passed down a laparo… | 1991 |
What descends from it? (255)
See all 2553 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K991859 (United States Surgical, A Division of Tyco Healthc, 1999) has gone furthest, with 234 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?
The Minisite* Bipolar Forceps** Device is indicate for use in laparoscopic bipolar coagulation.
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/K972415 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972415: Minisite*Bipolar Forceps** Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972415
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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