510(k) · Cleared
ClearedBipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 17, 2003 as substantially equivalent to K012279 (Patton Medical Corp., 2002) after a 63-day review. Its family tree reaches back 3 generations to 1994. 3 later devices descend from it.
- Decided
- Jan 17, 2003
- Review
- 63 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945975 (1994). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 2 generations backK971565 Bicoag Coagulating ForcepsEverest Medical Corp. · 1998
- 1 generation backK012279 Patton TripolPatton Medical Corp. · 2002
- This deviceK023813 Bipolar ForcepsRichard Wolf Medical Instruments Corp. · 2003
- Descendant · cites it directly · 1 of its ownK113597 Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies · 2012
- Descendant · 2 generations on · 0 of its ownK172775 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip…Teleflexmedical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK081553 Aed Bipolar Forceps, Model 13-1646National Advanced Endoscopy Devices, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K113597Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies · 2012 · cites it directly1descendant
- K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc. · 2018 · 2 generations on0descendants
- K081553Aed Bipolar Forceps, Model 13-1646National Advanced Endoscopy Devices, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −2 | K971565 | Bicoag Coagulating Forceps | Everest Medical Corp. | 1998 | — |
| −1 | K012279 | Patton Tripol | Patton Medical Corp. | 2002 | — |
| 0 (this device) | K023813 | Bipolar Forceps | Richard Wolf Medical Instruments Corp. | 2003 | — |
| +1 | K113597 | Mini-Lap Bipolar Electrocautery Devices | Minilap Technologies | 2012 | — |
| +2 | K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Teleflexmedical, Inc. | 2018 | — |
| +1 | K081553 | Aed Bipolar Forceps, Model 13-1646 | National Advanced Endoscopy Devices, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K012279 | Patton TripolSummary page 2…devices pose the same type of questions about safety or effective- ness as the existing devices. The submitted devices are the same devices cleared in 510(k) K012279, April 30, 2002. 5.0 Performance Data The submitted devices perform the same as the devices cleared in 510(k) KO1… | 2002 |
What descends from it? (3)
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 9 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K113597 (Minilap Technologies, 2012) has gone furthest, with 1 descendant 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 Bipolar Forceps is intended for use in open and laparoscopic surgeries where grasping, coagulating, and transecting of tissue is indicated.
The submitted Bipolar Forceps are indicated for both GYN and general laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023813: Bipolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023813
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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