510(k) · Cleared
ClearedBipolar Grasper and Bipolar Scissors for the Zeus Microwrist Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Computer Motion, Inc. · NAY System, Surgical, Computer Controlled Instrument
Cleared on Jun 24, 2003 as substantially equivalent to K904993 (Everest Medical Corp., 1991) after a 120-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jun 24, 2003
- Review
- 120 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904993 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK904993 Laparoscopic Electrosurgical DeviceEverest Medical Corp. · 1991
- This deviceK030578 Bipolar Grasper and Bipolar Scissors for the Zeus Microwrist…Computer Motion, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904993 | Laparoscopic Electrosurgical Device | Everest Medical Corp. | 1991 | — |
| 0 (this device) | K030578 | Bipolar Grasper and Bipolar Scissors for the Zeus Microwrist Surgical System | Computer Motion, Inc. | 2003 | — |
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 NAY? 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? (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 |
|---|---|---|---|
| * | K904993 | Laparoscopic Electrosurgical DeviceSummary page 1…asper and ZEUS Bipolar Scissors to the hand-held versions of these instruments: The LyonsTMDissecting Forceps manufactured by Gyrus Medical, (K904993) 0 The Evershears@,manufactured by Gyrus Medical, (K904993) 4) Description of the Device: This premarket notificatio… | 1991 |
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?
- Its one ancestor has no recall.
- 11 other devices also cite its predicate K904993.
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 Bipolar Grasper and Bipolar Scissors are instruments used with the ZEUS@MicroWristTMSurgical System. The Bipolar Grasper is intended to grasp, dissect, and coagulate tissue. The Bipolar Scissors provide mechanical cutting and bipolar coagulation. These bipolar instruments augment the means of performing electrosurgical procedures with the ZEUS@MicroWristTMSurgical System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030578: Bipolar Grasper and Bipolar Scissors for the Zeus Microwrist 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/K030578
Report an extraction error
Are you the manufacturer?
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