510(k) Report

510(k) · Cleared

Cleared

Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07

K002906510(k) TraditionalCleared Dec 15, 200088-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ethicon Endo-Surgery, Inc. · LFL Instrument, Ultrasonic Surgical

Cleared on Dec 15, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 69 later devices descend from it.

Decided
Dec 15, 2000
Review
88 days
Class
Class U
Product code
LFL
Recalls
None
Predicates
0

69 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2011: 4 descendants cleared2014: 7 descendants cleared2012: 2 descendants cleared2004: 1 descendant cleared2010: 3 descendants cleared2021: 4 descendants cleared2022: 4 descendants cleared2008: 3 descendants cleared2015: 3 descendants cleared2018: 6 descendants cleared2017: 6 descendants cleared2025: 4 descendants cleared2013: 3 descendants cleared2016: 4 descendants cleared2023: 2 descendants cleared2026: 3 descendants cleared2019: 2 descendants cleared2020: 2 descendants cleared2024: 4 descendants cleared200020052010201520202025
  1. This deviceK002906 Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03…Ethicon Endo-Surgery, Inc. · 2000
  2. Descendant · cites it directly · 39 of its ownK042777 Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc. · 2004
  3. Descendant · 2 generations on · 16 of its ownK093217 5 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 &…Intuitive Surgical, Inc. · 2010 · Recalled
  4. Descendant · 3 generations on · 15 of its ownK112584 5MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace…Intuitive Surgical, Inc. · 2011 · Recalled
  5. Descendant · cites it directly · 14 of its ownK050550 Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005
  6. Descendant · 2 generations on · 14 of its ownK051036 Harmonic Ace Curved Shears with Pistol Handle and Hand Control…Ethicon Endo-Surgery, Inc. · 2005

Showing 5 of 69 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22008: 32010: 32011: 42012: 22013: 32014: 72015: 32016: 42017: 62018: 62019: 22020: 22021: 42022: 42023: 22024: 42025: 42026: 3
2004high 7 (2014) · low 0 (2006)2026

Most influential descendants

Showing 5 of 69 · See all
  • K042777Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc. · 2004 · cites it directly39descendants
  • K0932175 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System)Intuitive Surgical, Inc. · 2010 · 2 generations on16descendants
  • K1125845MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert, Disposable…Intuitive Surgical, Inc. · 2011 · 3 generations on15descendants
  • K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc. · 2005 · cites it directly14descendants
  • K051036Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc. · 2005 · 2 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002906Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053…Ethicon Endo-Surgery, Inc.2000—
+1K042777Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc.2004—
+2K0932175 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System)Intuitive Surgical, Inc.20103
+3K1125845MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert…Intuitive Surgical, Inc.20111
+1K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.2005—
+2K051036Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P…Ethicon Endo-Surgery, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200830
201030
201140
201220
201330
201470
201530
201640
201760
201860
201920
202020
202140
202240
202320
202440
202540
202630
FIG. 1 — Lineage of K002906, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in LFL? 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 LFL device

  1. #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (69)

See all 69

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042777Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc.200439
K050550Gyrus General Purpose Electrosurgical GeneratorGyrus Medical, Inc.200514
K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.201211
K101990Ethicon Endo-Surgery Generator G11, Model GEN11Ethicon Endo-Sugery, LLC201111
K101797Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB…Covidien, Formerly Valleylab, A Division of Tyco20115
K101534Conmed Altrus Thermal Tissue Fusion SystemConmedcorp20101
K210567Ultrasonic Surgical SystemMiconvey Technologies Co., Ltd.20220
K211273Harmonic Hand Piece, Blue, Harmonic Hand Piece, GrayEthicon Endo-Surgery, LLC20210
K140459Altrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece…Conmed Corporation20140
K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC20140

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?

  • Of its descendants, K042777 (Ethicon Endo-Surgery, Inc., 2004) has gone furthest, with 39 descendants of its own.

How does its category compare?

All LFL devices

LFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LFL

3in 2025

2007: 72008: 22009: 12010: 22011: 32012: 32013: 52014: 32015: 42016: 52017: 22018: 32019: 42020: 42021: 62022: 82023: 42024: 32025: 32026 (partial year): 3
2007high 8 (2022) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFL

176in 2025

2007: 99 days median2011: 241 days median2012: 82 days median2013: 73 days median2014: 136 days median2015: 99 days median2016: 111 days median2018: 66 days median2019: 103 days median2020: 190 days median2021: 83 days median2022: 168 days median2023: 104 days median2024: 158 days median2025: 176 days median2026 (partial year): 99 days median
2007high 241 (2011) · low 66 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LFL

11in 2024

2010: 32011: 22012: 52014: 12015: 12017: 12019: 422021: 12023: 22024: 112026 (partial year): 1
2007high 42 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFL

3,857in 2025

2007: 2,2362008: 1,6782009: 3,3242010: 1,2392011: 1,0532012: 1,4912013: 2,4302014: 4,2602015: 2,7772016: 2,6912017: 3,2672018: 3,4612019: 3,1532020: 2,9342021: 3,2892022: 3,4222023: 4,2152024: 4,0172025: 3,857
2007high 4,260 (2014) · low 1,053 (2011)2025

MAUDE reports naming product code LFL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200779902,236
20082—01,678
20091—03,324
20102—31,239
2011324121,053
201238251,491
201357302,430
2014313614,260
201549912,777
2016511102,691
20172—13,267
201836603,461
20194103423,153
2020419002,934
202168313,289
2022816803,422
2023410424,215
20243158114,017
2025317603,857
20263991—

More from Ethicon Endo-Surgery, Inc.

111 FDA decisions under this applicant name. See the company

  • K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon Vascular White Reloads…Ethicon Endo-Surgery, Inc. · 20141 Class I recall
  • K111195Valutrus Reusable Circular Stapler and Disposable ReloadsEthicon Endo-Surgery, Inc. · 2011
  • K110385Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 2011
  • K101520Enseal Tissue Sealing Devices Model: NSEAL514H-535H, NSEAL514RH-535RHEthicon Endo-Surgery, Inc. · 2010
  • K102632Ethicon Endo-Surgery 5MM Laparoscopic Multi-Feed StaplerEthicon Endo-Surgery, Inc. · 2010

Recent decisions in LFL

The LFL category page

  • K261361TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque…Carl Zeiss Meditec, AG · 2026
  • K262244Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+…Stryker Instruments · 2026
  • K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC · 2026
  • K251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2025
  • K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced…Shanghai Saints Sages Surgical Co., Ltd. · 2025

https://510kreport.com/device/K002906 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002906: Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002906

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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