510(k) Report

510(k) · Cleared

Cleared

Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36P

K042777510(k) TraditionalCleared Dec 1, 200456-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 1, 2004 as substantially equivalent to K993054 (Ethicon Endo-Surgery, Inc., 1999) and 1 other predicate after a 56-day review. Its family tree reaches back 3 generations to 1993. 39 later devices descend from it.

Decided
Dec 1, 2004
Review
56 days
Class
Class U
Product code
LFL
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K925699 (1993). 5 ancestors in all. 39 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1997: 1 other ancestor2011: 2 descendants cleared2005: 1 descendant cleared2010: 1 descendant cleared2022: 3 descendants cleared2012: 1 descendant cleared2013: 2 descendants cleared2014: 3 descendants cleared2015: 2 descendants cleared2018: 6 descendants cleared2017: 5 descendants cleared2021: 2 descendants cleared2019: 2 descendants cleared2016: 1 descendant cleared2023: 2 descendants cleared2025: 2 descendants cleared2026: 2 descendants cleared2020: 1 descendant cleared2024: 1 descendant clearedK925699 · Harmonic Scalpel Laparosonic Clamp Coagulator Acc. · Ultracision, Inc. · 1993K980099 · Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)) · Ethicon Endo-Surgery, Inc. · 1998K993054 · Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 · Ethicon Endo-Surgery, Inc. · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 9 descendants3 generations forward: 9 descendants4 generations forward: 7 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant7 generations forward: 2 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant10 generations forward: 1 descendant11 generations forward: 1 descendant K993054 · Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 · Ethicon Endo-Surgery, Inc. · 1999K980099 · Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5)) · Ethicon Endo-Surgery, Inc. · 1998K925699 · Harmonic Scalpel Laparosonic Clamp Coagulator Acc. · Ultracision, Inc. · 19930+5+10
  1. Root · 3 generations backK925699 Harmonic Scalpel Laparosonic Clamp Coagulator Acc.Ultracision, Inc. · 1993
  2. 2 generations backK980099 Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Ethicon Endo-Surgery, Inc. · 1998
  3. 1 generation backK993054 Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5…Ethicon Endo-Surgery, Inc. · 1999
  4. This deviceK042777 Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc. · 2004
  5. Descendant · cites it directly · 16 of its ownK093217 5 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 &…Intuitive Surgical, Inc. · 2010 · Recalled
  6. Descendant · 2 generations on · 15 of its ownK112584 5MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace…Intuitive Surgical, Inc. · 2011 · Recalled
  7. Descendant · cites it directly · 14 of its ownK051036 Harmonic Ace Curved Shears with Pistol Handle and Hand Control…Ethicon Endo-Surgery, Inc. · 2005
  8. Descendant · 2 generations on · 11 of its ownK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · Recalled
  9. Descendant · 3 generations on · 9 of its ownK143132 IS4000 8mm Harmonic ACE Curved ShearsIntuitive Surgical, Inc. · 2015

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2005: 12010: 12011: 22012: 12013: 22014: 32015: 22016: 12017: 52018: 62019: 22020: 12021: 22022: 32023: 22024: 12025: 22026: 2
2005high 6 (2018) · low 0 (2006)2026

Most influential descendants

Showing 5 of 39 · See all
  • K0932175 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System)Intuitive Surgical, Inc. · 2010 · cites it directly16descendants
  • K1125845MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert, Disposable…Intuitive Surgical, Inc. · 2011 · 2 generations on15descendants
  • K051036Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc. · 2005 · cites it directly14descendants
  • K111202Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · 2 generations on11descendants
  • K143132IS4000 8mm Harmonic ACE Curved ShearsIntuitive Surgical, Inc. · 2015 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K925699Harmonic Scalpel Laparosonic Clamp Coagulator Acc.Ultracision, Inc.1993—
−2K980099Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))Ethicon Endo-Surgery, Inc.1998—
−1K993054Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1…Ethicon Endo-Surgery, Inc.1999—
0 (this device)K042777Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc.2004—
+1K0932175 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System)Intuitive Surgical, Inc.20103
+2K1125845MM/8MM Harmonic Ace (TM) Curved Shears, Disposable Harmonic Ace (TM) Insert…Intuitive Surgical, Inc.20111
+1K051036Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P…Ethicon Endo-Surgery, Inc.2005—
+2K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.201210
+3K143132IS4000 8mm Harmonic ACE Curved ShearsIntuitive Surgical, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201010
201120
201210
201320
201430
201520
201610
201750
201860
201920
202010
202120
202230
202320
202410
202520
202620
FIG. 1 — Lineage of K042777, 1993–2026Source: 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), 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 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K993054Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231…
Summary page 1
…h Hand Control Classification Name: Electrosurgical Cutting and Coagulation Device Predicate Devices: UltraCision®)Harmonic Scalpel(®0 Curved Shears (LCS) cleared under K993054 on 12/09/1999 and UltraCision® Harmonic Scalpel®R Hand Switching Adaptor cleared under K002906 on 12/15/2000 Device Description…
Ethicon Endo-Surgery, Inc.1999—
*K002906Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07
Summary page 1
…evices: UltraCision®)Harmonic Scalpel(®0 Curved Shears (LCS) cleared under K993054 on 12/09/1999 and UltraCision® Harmonic Scalpel®R Hand Switching Adaptor cleared under K002906 on 12/15/2000 Device Description The Harmonic ACETM Curved Shears with Hand Control is a sterile, single patient use instrument…
Ethicon Endo-Surgery, Inc.2000—

Also cleared against K993054: 5 other devices →

What descends from it? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K0932175 MM Harmonic Ace Instrument (Used with DA Vinci IS1200 & IS2000/IS3000 System)Intuitive Surgical, Inc.201016
K051036Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36PEthicon Endo-Surgery, Inc.200514
K101797Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB…Covidien, Formerly Valleylab, A Division of Tyco20115
K210567Ultrasonic Surgical SystemMiconvey Technologies Co., Ltd.20220

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?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K093217 (Intuitive Surgical, Inc., 2010) has gone furthest, with 16 descendants of its own.
  • 5 other devices also cite its predicate K993054.

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—

What is it indicated for?

The Harmonic ACETM Curved Shears with Hand Control is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, pediatric, gynecologic, urologic and other open and endoscopic procedures.

Indications for use as stated in the FDA summary.

Also cleared against K993054

5 other devices cite the same predicate.

  • K043358Reprocessed Ultrasonic ScalpelsAlliance Medical Corp. · 2005
  • K043315Vanguard Reprocessed Hand-Activated Ultrasonic ScalpelVanguard Medical Concepts, Inc. · 2005
  • K043225Vanguard Reprocessed Ultrasonic ScalpelVanguard Medical Concepts, Inc. · 2005
  • K042855Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc. · 2004
  • K030598Medisiss Reprocessed Ultrasonic Surgical InstrumentsMedisiss · 2004

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/K042777 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042777: Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042777

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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