510(k) · Cleared
ClearedMSD Bipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 5, 2006 as substantially equivalent to K051429 (Guenter Bissinger Medizintechnik GmbH, 2005) after an 85-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Sep 5, 2006
- Review
- 85 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K923332 (1992). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
- 3 generations backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
- 2 generations backK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
- 1 generation backK051429 Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2005
- This deviceK061635 MSD Bipolar ForcepsMedtronic Sofamor Danek · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923332 | Electrosurgical Electrodes | Premier Dental Products Co. | 1992 | — |
| −3 | K970987 | Electrosurgical Electrode | Fusion Medical Technologies, Inc. | 1997 | — |
| −2 | K992931 | Non-Stick Bipolar Forceps | Silverglide Surgical Technologies | 1999 | — |
| −1 | K051429 | Claris Non-Stick Bipolar Forceps | Guenter Bissinger Medizintechnik GmbH | 2005 | — |
| 0 (this device) | K061635 | MSD Bipolar Forceps | Medtronic Sofamor Danek | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K051429 | Claris Non-Stick Bipolar ForcepsSummary page 1…ich demonstrated the subject MSD BIPOLAR Forceps to be substantially equivalent to the CLARIS Non-Stick Bipolar Forceps previously cleared by the agency in K051429 (SE 07/29/05). 0000t C === Page 2 ==… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 7 other devices also cite its predicate K051429.
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 MSD BIPOLAR Forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current. The MSD BIPOLAR Forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061635: MSD 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/K061635
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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