510(k) · Cleared
ClearedHarmonic Scalpel Laparosonic Clamp Coagulator Acc.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultracision, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 17, 1993 after a 186-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 of the 469 devices in its family, counting itself, have a Class I recall. 468 later devices descend from it.
- Decided
- May 17, 1993
- Review
- 186 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
468 later devices descend from it, 5 citing it directly. 5 of the 469 devices in this family, counting this one, have a Class I recall.
- This deviceK925699 Harmonic Scalpel Laparosonic Clamp Coagulator Acc.Ultracision, Inc. · 1993
- Descendant · cites it directly · 268 of its ownK980099 Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Ethicon Endo-Surgery, Inc. · 1998
- Descendant · cites it directly · 263 of its ownK993054 Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5…Ethicon Endo-Surgery, Inc. · 1999
- Descendant · 2 generations on · 235 of its ownK042855 Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc. · 2004
- Descendant · 3 generations on · 229 of its ownK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- Descendant · 3 generations on · 229 of its ownK043288 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
Showing 5 of 468 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 468 · See all- K980099Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Ethicon Endo-Surgery, Inc. · 1998 · cites it directly268descendants
- K993054Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231…Ethicon Endo-Surgery, Inc. · 1999 · cites it directly263descendants
- K042855Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc. · 2004 · 2 generations on235descendants
- K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · 3 generations on229descendants
- K043288Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · 3 generations on229descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925699 | Harmonic Scalpel Laparosonic Clamp Coagulator Acc. | Ultracision, Inc. | 1993 | — |
| +1 | K980099 | Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| +1 | K993054 | Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1… | Ethicon Endo-Surgery, Inc. | 1999 | — |
| +2 | K042855 | Intuitive Surgical Harmonic Curved Shears Instrument | Intuitive Surgical, Inc. | 2004 | — |
| +3 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| +3 | K043288 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 13 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 10 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 12 | 0 |
| 2012 | 10 | 0 |
| 2013 | 18 | 0 |
| 2014 | 24 | 0 |
| 2015 | 16 | 0 |
| 2016 | 26 | 1 |
| 2017 | 24 | 2 |
| 2018 | 31 | 0 |
| 2019 | 18 | 0 |
| 2020 | 32 | 1 |
| 2021 | 27 | 0 |
| 2022 | 30 | 0 |
| 2023 | 27 | 1 |
| 2024 | 29 | 0 |
| 2025 | 45 | 0 |
| 2026 | 32 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 devices in this family have 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (468)
See all 4685 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980099 | Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)) | 1998 | 268 |
| K993054 | Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231… | 1999 | 263 |
| K972114 | Olympus Sonosurg System | 1998 | 213 |
| K043315 | Vanguard Reprocessed Hand-Activated Ultrasonic Scalpel | 2005 | 0 |
| K043225 | Vanguard Reprocessed Ultrasonic Scalpel | 2005 | 0 |
Has anything in its family been recalled? (5 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 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 10 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 10 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 11 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 12 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- Of its descendants, K980099 (Ethicon Endo-Surgery, Inc., 1998) has gone furthest, with 268 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
https://510kreport.com/device/K925699 · printed Nov 4, 2026
Cite this page
510(k) Report. “K925699: Harmonic Scalpel Laparosonic Clamp Coagulator Acc..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K925699
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026