510(k) · Cleared
Recalled · Class II · 2013Intuitive Surgical Bipolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · NAY System, Surgical, Computer Controlled Instrument
Cleared on Nov 16, 2001 as substantially equivalent to K991859 (United States Surgical, A Division of Tyco Healthc, 1999) and 1 other predicate after an 85-day review. Its family tree reaches back 3 generations to 1991. 1 of the 242 devices in its family, counting itself, has a Class I recall. 233 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 16, 2001
- Review
- 85 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 3 generations to K912544 (1991). 8 ancestors in all. 233 later devices descend from it, 6 citing it directly. 1 of the 242 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK912544 Bipolar ForcepsEverest Medical Corp. · 1991
- 2 generations backK972415 Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997
- 1 generation backK991859 Dexide Bipolar Forceps II ** DeviceUnited States Surgical, A Division of Tyco Healthc · 1999
- This deviceK012833 Intuitive Surgical Bipolar ForcepsIntuitive Surgical, Inc. · 2001
- Descendant · cites it directly · 229 of its ownK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- Descendant · cites it directly · 228 of its ownK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- Descendant · 2 generations on · 224 of its ownK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 211 of its ownK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 155 of its ownK060391 Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · Recalled
Showing 5 of 233 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223095 Senhance Surgical System3 generations on · 2023
Most influential descendants
Showing 5 of 233 · See all- K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · cites it directly229descendants
- K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · cites it directly228descendants
- K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · 2 generations on224descendants
- K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · 3 generations on211descendants
- K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · 2 generations on155descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912544 | Bipolar Forceps | Everest Medical Corp. | 1991 | — |
| −2 | K972415 | Minisite*Bipolar Forceps** Device | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −1 | K991859 | Dexide Bipolar Forceps II ** Device | United States Surgical, A Division of Tyco Healthc | 1999 | — |
| 0 (this device) | K012833 | Intuitive Surgical Bipolar Forceps | Intuitive Surgical, Inc. | 2001 | — |
| +1 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| +1 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| +2 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| +3 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| +2 | K060391 | Intuitive Surgical Endowrist Stabilizer, Model 420182 | Intuitive Surgical, Inc. | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 10 | 0 |
| 2015 | 4 | 0 |
| 2016 | 9 | 0 |
| 2017 | 14 | 0 |
| 2018 | 16 | 0 |
| 2019 | 9 | 0 |
| 2020 | 17 | 0 |
| 2021 | 16 | 0 |
| 2022 | 18 | 0 |
| 2023 | 19 | 1 |
| 2024 | 22 | 0 |
| 2025 | 31 | 0 |
| 2026 | 22 | 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.
1 device in this family has a Class I recall. 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 NAY device
- #1 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K991859 | Dexide Bipolar Forceps II ** DeviceSummary page 1…§878.4400) Trade Name: Intuitive Surgical® Endowrist™ Bipolar Forceps Common Namé: Bipolar Forceps Predicate Device(s): United States Sprgical Dexide Bipolar Forceps K991859 Intuitive Surgical da Vinci Surgical System K990144 Device Description: The Intuitive Surgical® Bipolar Forceps is an endoscop… | 1999 |
| * | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Summary page 1…t™ Bipolar Forceps Common Namé: Bipolar Forceps Predicate Device(s): United States Sprgical Dexide Bipolar Forceps K991859 Intuitive Surgical da Vinci Surgical System K990144 Device Description: The Intuitive Surgical® Bipolar Forceps is an endoscopic instrument with a graspfng end effector to be used… | 2000 |
What descends from it? (233)
See all 2336 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | 2005 | 229 |
| K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | 2005 | 228 |
| K061260 | Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214 | 2006 | 154 |
| K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 | 2009 | 153 |
| K110639 | Endowrist One Vessel Sealer | 2011 | 15 |
| K123329 | DA Vinvi Surgical System | 2014 | 3 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2013 | Class II | Z-1432-2013 | Device Design | Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments. |
| May 8, 2013 | Class II | Z-1431-2013 | Device Design | Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments. |
| May 8, 2013 | Class II | Z-1433-2013 | Device Design | Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments. |
| Mar 24, 2005 | Not classified | Z-0660-2007 | Other | The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K050404 (Intuitive Surgical, Inc., 2005) has gone furthest, with 229 descendants of its own.
How does its category compare?
All NAY devicesNAY System, Surgical, Computer Controlled Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAY
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NAY
117in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NAY
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NAY
48,456in 2025
MAUDE reports naming product code NAY, 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 | 0 | — | 11 | 133 |
| 2008 | 4 | 189 | 3 | 224 |
| 2009 | 3 | 253 | 1 | 380 |
| 2010 | 1 | — | 0 | 623 |
| 2011 | 7 | 191 | 2 | 501 |
| 2012 | 4 | 106 | 1 | 1,552 |
| 2013 | 4 | 144 | 6 | 6,217 |
| 2014 | 9 | 143 | 25 | 6,135 |
| 2015 | 3 | 99 | 3 | 1,722 |
| 2016 | 8 | 197 | 1 | 1,077 |
| 2017 | 16 | 107 | 1 | 1,049 |
| 2018 | 15 | 152 | 2 | 1,074 |
| 2019 | 8 | 73 | 5 | 1,154 |
| 2020 | 9 | 212 | 0 | 1,558 |
| 2021 | 11 | 61 | 3 | 1,997 |
| 2022 | 6 | 57 | 3 | 5,727 |
| 2023 | 5 | 141 | 2 (1) | 10,898 |
| 2024 | 10 | 126 | 40 | 12,872 |
| 2025 | 16 | 117 | 1 | 48,456 |
| 2026 | 7 | 89 | 4 (1) | — |
What is it indicated for?
The Intuitive Surgical® Bipolar Forceps is intended for use with the da Vinci™ Surgical System to grasp, retract, coagulate and transect soft tissues during endoscopic surgical procedures.
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/K012833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012833: Intuitive Surgical 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/K012833
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026