510(k) · Cleared
ClearedSelect-Sutter Micro Bipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Select Medizintechnik Hermann Sutter GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 25, 1999 as substantially equivalent to K972415 (United States Surgical, A Division of Tyco Healthc, 1997) after a 69-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Oct 25, 1999
- Review
- 69 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912544 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK912544 Bipolar ForcepsEverest Medical Corp. · 1991
- 1 generation backK972415 Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997
- This deviceK992760 Select-Sutter Micro Bipolar ForcepsSelect Medizintechnik Hermann Sutter GmbH · 1999
- Descendant · cites it directly · 0 of its ownK012033 Multifunction Endoscopic InstrumentSeedling Enterprises., LLC · 2001
Most influential descendants
Showing 1 of 1 · See all- K012033Multifunction Endoscopic InstrumentSeedling Enterprises., LLC · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912544 | Bipolar Forceps | Everest Medical Corp. | 1991 | — |
| −1 | K972415 | Minisite*Bipolar Forceps** Device | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| 0 (this device) | K992760 | Select-Sutter Micro Bipolar Forceps | Select Medizintechnik Hermann Sutter GmbH | 1999 | — |
| +1 | K012033 | Multifunction Endoscopic Instrument | Seedling Enterprises., LLC | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K972415 | Minisite*Bipolar Forceps** DeviceSummary page 1…ng and Coagulation Device and Accessories, Laparoscopic Micro Bipolar Forceps Select-Sutter Micro-Bipolar Forceps MiniSite® Bipolar Forceps, U.S. Surgical Corporation (K972415) The Micro-Bipolar Forceps Device is a laparoscopic and endoscopic device used for the grasping and general coagulation/cutting… | 1997 |
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 |
|---|---|---|---|
| K012033 | Multifunction Endoscopic Instrument | 2001 | 0 |
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 8 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K012033 (Seedling Enterprises., LLC, 2001) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K972415.
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 Select-Sutter Micro-Bipolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general surgery where coagulation of soft tissue is needed. This product is used with bipolar output of standard electrosurgical generators. The types of surgery intended are:
General sugery
Laparoscopic procedures
Endoscopic procedures
Laryngeal coagulation
Orthopedic coagulation
Thorascopic coagulation
Neurosurgical coagulation
Gynecological coagulation, (except for use in female sterilization)
Ear, Nose and Throat 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/K992760 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992760: Select-Sutter Micro Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992760
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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