510(k) Report

510(k) · Cleared

Cleared

Harmonic Scalpel Laparosonic Blade Accessory

K924281510(k) TraditionalCleared Apr 23, 1993241-day reviewClass II21 CFR 876.1500

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

Ultracision, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Apr 23, 1993 after a 241-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 34 later devices descend from it.

Decided
Apr 23, 1993
Review
241 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

34 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2010: 1 descendant cleared2003: 1 descendant cleared2016: 4 descendants cleared2005: 2 descendants cleared2012: 2 descendants cleared2004: 1 descendant cleared2013: 1 descendant cleared2014: 3 descendants cleared2024: 1 descendant cleared2017: 3 descendants cleared2021: 2 descendants cleared2015: 2 descendants cleared2019: 1 descendant cleared2020: 2 descendants cleared2018: 4 descendants cleared2023: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK924281 Harmonic Scalpel Laparosonic Blade AccessoryUltracision, Inc. · 1993
  2. Descendant · cites it directly · 33 of its ownK990362 Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc. · 1999
  3. Descendant · 2 generations on · 18 of its ownK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
  4. Descendant · 2 generations on · 18 of its ownK031710 Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2003
  5. Descendant · 3 generations on · 15 of its ownK050885 Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation · 2005
  6. Descendant · 3 generations on · 11 of its ownK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · Recalled

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

1999: 12003: 12004: 12005: 22010: 12012: 22013: 12014: 32015: 22016: 42017: 32018: 42019: 12020: 22021: 22023: 12024: 12025: 12026: 1
1999high 4 (2016) · low 0 (2000)2026

Most influential descendants

Showing 5 of 34 · See all
  • K990362Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc. · 1999 · cites it directly33descendants
  • K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010 · 2 generations on18descendants
  • K031710Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2003 · 2 generations on18descendants
  • K050885Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation · 2005 · 3 generations on15descendants
  • K111202Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924281Harmonic Scalpel Laparosonic Blade AccessoryUltracision, Inc.1993—
+1K990362Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc.1999—
+2K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC2010—
+2K031710Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd.2003—
+3K050885Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation2005—
+3K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200310
200410
200520
201010
201220
201310
201430
201520
201640
201730
201840
201910
202020
202120
202310
202410
202510
202610
FIG. 1 — Lineage of K924281, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GCJ? 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. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (34)

See all 34

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990362Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc.199933

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, K990362 (Ethicon Endo-Surgery, Inc., 1999) has gone furthest, with 33 descendants of its own.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

More from Ultracision, Inc.

9 FDA decisions under this applicant name. See the company

  • K952726Ultracision Harmonic ScapelUltracision, Inc. · 1995
  • K941897Ultracison Harmonic Scalpel HS2 BladeUltracision, Inc. · 1994
  • K930352Harmonic Scalpel Reusable Laporascopic Blade Syst.Ultracision, Inc. · 1993
  • K924917Harmonic Scalpel 5MM Laparosonic Blade AccessoryUltracision, Inc. · 1993
  • K925699Harmonic Scalpel Laparosonic Clamp Coagulator Acc.Ultracision, Inc. · 1993

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https://510kreport.com/device/K924281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924281: Harmonic Scalpel Laparosonic Blade Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924281

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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