510(k) · Cleared
ClearedBipolar HF Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 28, 2011 as substantially equivalent to K952524 (Aesculap, Inc., 1995) and 3 other predicates after a 106-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Jun 28, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K932293 (1994). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK932293 Cabot Medical Bipolar Cutting ForcepsCabot Medical Corp. · 1994 · Recalled
- 3 generations backK981916 Ligasure Vessel Sealing SystemValleylab, Inc. · 1998
- 2 generations backK051644 Valleylab Forcetriad Electrosurgical GeneratorValleylab · 2005
- 1 generation backK102913 ForcetriadCovidien, Formerly Valleylab, A Division of Tyco H · 2011
- This deviceK110695 Bipolar HF DeviceAesculap, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932293 | Cabot Medical Bipolar Cutting Forceps | Cabot Medical Corp. | 1994 | 3 |
| −3 | K981916 | Ligasure Vessel Sealing System | Valleylab, Inc. | 1998 | — |
| −2 | K051644 | Valleylab Forcetriad Electrosurgical Generator | Valleylab | 2005 | — |
| −1 | K102913 | Forcetriad | Covidien, Formerly Valleylab, A Division of Tyco H | 2011 | — |
| 0 (this device) | K110695 | Bipolar HF Device | Aesculap, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 6 | 0 |
| 1996 | 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? (4)
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 |
|---|---|---|---|
| * | K952524 | Aesculap Biopolar CoagulatorSummary page 1…Aesculap Bipolar HF Device as described in this premarket notification is substantially equivalent to the following predicate devices: * Aesculap, Bipolar Coagulator (K952524) * Wolf Model 2352 (K945914) * Valleylabs Force FZ (K953195) * Valleylabs Forcetriad (Ki 02913) DEVICE DESCRIPTION Aesc… | 1995 |
| * | K945914 | Bipolar Generator Model 2352Summary page 1…escribed in this premarket notification is substantially equivalent to the following predicate devices: * Aesculap, Bipolar Coagulator (K952524) * Wolf Model 2352 (K945914) * Valleylabs Force FZ (K953195) * Valleylabs Forcetriad (Ki 02913) DEVICE DESCRIPTION Aesculap's Bipolar HF Device is a n… | 1995 |
| * | K953195 | Valleylab Force 300Summary page 1…tion is substantially equivalent to the following predicate devices: * Aesculap, Bipolar Coagulator (K952524) * Wolf Model 2352 (K945914) * Valleylabs Force FZ (K953195) * Valleylabs Forcetriad (Ki 02913) DEVICE DESCRIPTION Aesculap's Bipolar HF Device is a non-sterile, reusable electrosurgica… | 1995 |
| * | K102913 | Forcetriad Cleared while this submission was under review Summary page 1…iples to the following predicate devices: Aesculap Bipolar Coagulator (K952524), Wolf Model 2352 (K945914), Valleylabs Force FZ (K953195), and the Valleylabs Forcetriad (K102913). Testing of the subject device was found to be similar in performance to the previously cleared device with simi… | 2011 |
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 17 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 11 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Aesculap's Bipolar Coagulator (GN16O) is intended for use in surgery to generate electrical
power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery,
urology, laparoscopy, and plastic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110695: Bipolar HF Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110695
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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