510(k) · Cleared
ClearedDoro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables, Model 5015-XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pro-Med Instruments GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 16, 2007 as substantially equivalent to K051429 (Guenter Bissinger Medizintechnik GmbH, 2005) and 1 other predicate after a 37-day review. Its family tree reaches back 4 generations to 1992. 14 later devices descend from it.
- Decided
- May 16, 2007
- Review
- 37 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K923332 (1992). 6 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- 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 deviceK070997 Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro…Pro-Med Instruments GmbH · 2007
- Descendant · cites it directly · 13 of its ownK083162 Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 10 of its ownK093108 Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG · 2010
- Descendant · 3 generations on · 3 of its ownK152219 PK AIMGyrus Acmi, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
- Descendant · 4 generations on · 2 of its ownK161825 PK AIMGyrus Acmi, Inc. · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K083162Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 2009 · cites it directly13descendants
- K093108Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG · 2010 · 2 generations on10descendants
- K152219PK AIMGyrus Acmi, Inc. · 2015 · 3 generations on3descendants
- K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011 · 3 generations on3descendants
- K161825PK AIMGyrus Acmi, Inc. · 2016 · 4 generations on2descendants
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) | K070997 | Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar… | Pro-Med Instruments GmbH | 2007 | — |
| +1 | K083162 | Stingray Electrosurgical Forceps | Stingray Surgical Products, Inc. | 2009 | 1 |
| +2 | K093108 | Stryker Bipolar Forceps | Stryker Leibinger GmbH & Co KG | 2010 | — |
| +3 | K152219 | PK AIM | Gyrus Acmi, Inc. | 2015 | — |
| +3 | K110143 | Het Bipolar Electrocautery Forceps | Het Systems, LLC | 2011 | — |
| +4 | K161825 | PK AIM | Gyrus Acmi, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051429 | Claris Non-Stick Bipolar ForcepsSummary page 2…The DORO®D Bipolar Reusable Gables are equivalent to the Stryker Silverglide Bipolar Forceps Reusable Cables (K0618635) and nearly equivalent to CLARIS bipolar forceps (K051429) except small changes of the material. The DORO® Bipolar Reusable Cables are non-sterile, reusable bipolar cables of 3 and 5 mete… | 2005 |
| * | K992931 | Non-Stick Bipolar ForcepsSummary page 1…turers, GOnter Bissinger Medizintechnik GmbH (product: CLARIS NON-STICK bipolar forceps, K51429), e.g. Link Technology, Inc. (product: Silverglide Surgical Technologies, K992931). The DORO® Non-Stick Bipolar Forceps are for use in general surgical procedures. These devices are connected through a suitable… | 1999 |
| Kept off the family tree | K061863 | FDA’s K061863 is Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family Our reading of the summary gave K061863, FDA’s number for Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family (Arthrex, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Stryker Silverglide Bipolar Forceps Reusable Cables”. Kept off the family tree. Summary page 2…APPENDIX I: Summary (b) DORO® Bipolar Reusable Cables The DORO®D Bipolar Reusable Gables are equivalent to the Stryker Silverglide Bipolar Forceps Reusable Cables (K0618635) and nearly equivalent to CLARIS bipolar forceps (K051429) except small changes of the material. The DORO® Bipolar Reusable Cabl… | 2006 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083162 | Stingray Electrosurgical Forceps | 2009 | 13 |
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 15 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.
- Of its descendants, K083162 (Stingray Surgical Products, Inc., 2009) has gone furthest, with 13 descendants of its own.
- 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. 2007, 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 DORO® Bipolar Reusable Cables are designed to conduct electrical power from the output of a high frequency electrosurgical generator to the instrument. The DORO ® Non-Stick Bipolar Forceps are designed to grasp, manipulate and coagulate selected tissue and are intended for use in general surgical procedures, They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used…
Read the full statement (119 words)
The DORO® Bipolar Reusable Cables are designed to conduct electrical power from the output of a high frequency electrosurgical generator to the instrument.
The DORO ® Non-Stick Bipolar Forceps are designed to grasp, manipulate and coagulate selected tissue and are intended for use in general surgical procedures, They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch,
The DORO® NON-STICK Bipolar Forceps have 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/K070997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070997: Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables, Model 5015-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070997
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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