510(k) · Cleared
ClearedSenhance Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asensus Surgical, Inc. · NAY System, Surgical, Computer Controlled Instrument
Cleared on Jul 19, 2024 as substantially equivalent to K223095 (Asensus Surgical, Inc., 2023) and 1 other predicate after a 226-day review. Its family tree reaches back 21 generations to 1994. 1 of the 68 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 19, 2024
- Review
- 226 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K930667 (1994). 67 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet. 1 of the 68 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 17 generations between
- 3 generations backK212054 Senhance Surgical SystemAsensus Surgical, Inc. · 2021
- 2 generations backK220889 Senhance Surgical SystemAsensus Surgical, Inc. · 2022
- 1 generation backK223095 Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · Recalled (Class I)
- This deviceK233866 Senhance Surgical SystemAsensus Surgical, Inc. · 2024
Show all 21 generations
- Root · 21 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 20 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 19 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 18 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 17 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 16 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 15 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 14 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 13 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 12 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 11 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 10 generations backK171120 Senhance Surgical Robotic SystemTransenterix, Inc. · 2017
- 9 generations backK180163 TransEnterix Senhance Surgical SystemTransenterix, Inc. · 2018
- 8 generations backK181517 Senhance Surgical SystemTransenterix, Inc. · 2018
- 7 generations backK191482 Senhance Surgical SystemTransenterix, Inc. · 2019
- 6 generations backK192877 Senhance Surgical SystemTransenterix, Inc. · 2019
- 5 generations backK200049 Senhance Surgical SystemTransenterix, Inc. · 2020
- 4 generations backK202166 Senhance Surgical SystemTransenterix, Inc. · 2021
- 3 generations backK212054 Senhance Surgical SystemAsensus Surgical, Inc. · 2021
- 2 generations backK220889 Senhance Surgical SystemAsensus Surgical, Inc. · 2022
- 1 generation backK223095 Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · Recalled (Class I)
- This deviceK233866 Senhance Surgical SystemAsensus Surgical, Inc. · 2024
Class I recalls in this family
- K223095 Senhance Surgical Systemdirect predicate · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −20 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −19 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −18 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −17 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −16 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −15 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −14 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −13 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −12 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −11 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −10 | K171120 | Senhance Surgical Robotic System | Transenterix, Inc. | 2017 | — |
| −9 | K180163 | TransEnterix Senhance Surgical System | Transenterix, Inc. | 2018 | — |
| −8 | K181517 | Senhance Surgical System | Transenterix, Inc. | 2018 | — |
| −7 | K191482 | Senhance Surgical System | Transenterix, Inc. | 2019 | — |
| −6 | K192877 | Senhance Surgical System | Transenterix, Inc. | 2019 | — |
| −5 | K200049 | Senhance Surgical System | Transenterix, Inc. | 2020 | — |
| −4 | K202166 | Senhance Surgical System | Transenterix, Inc. | 2021 | — |
| −3 | K212054 | Senhance Surgical System | Asensus Surgical, Inc. | 2021 | — |
| −2 | K220889 | Senhance Surgical System | Asensus Surgical, Inc. | 2022 | — |
| −1 | K223095 | Senhance Surgical System | Asensus Surgical, Inc. | 2023 | Class I |
| 0 (this device) | K233866 | Senhance Surgical System | Asensus Surgical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 7 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 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 |
|---|---|---|---|
| * | K223095 | Senhance Surgical SystemSummary page 4…NAY (System, Surgical, Computer Controlled Instrument) Predicate Device Information Primary Predicate Device: Senhance® Surgical System (K223095) Reference Device: Intuitive Surgical da Vinci Si Surgical System (K171699)… | 2023 |
| * | K171699 | da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemSummary page 4…nformation Primary Predicate Device: Senhance® Surgical System (K223095) Reference Device: Intuitive Surgical da Vinci Si Surgical System (K171699) 1 510(k) #: K233866 Device Description The Senhance Su… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 16 of the 67 ancestors have a recall of any class; 1 has a Class I recall.
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. 2024, this device’s year, is highlighted.
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 Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures, laparoscopic gynecological surgery, and laparoscopic urological…
Read the full statement (119 words)
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures, laparoscopic gynecological surgery, and laparoscopic urological surgery. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
Use of the device is limited to patients two (2) years of age and older and a weight equal to or above 10kg, who are suitable to be subjected to a conventional endoscopic technique.
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/K233866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233866: Senhance Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233866
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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