510(k) Report

510(k) · Cleared

Cleared

Instrument, Ultrasonic, Scalpel

K990362510(k) TraditionalCleared Sep 17, 1999224-day reviewClass II21 CFR 878.4400

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. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Sep 17, 1999 as substantially equivalent to K983316 (Ethicon Endo-Surgery, Inc., 1998) and 6 other predicates after a 224-day review. Its family tree reaches back 1 generation to 1988. 33 later devices descend from it.

Decided
Sep 17, 1999
Review
224 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
8

Its longest line of descent runs back 1 generation to K881763 (1988). 7 ancestors in all. 33 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor2010: 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 clearedK881763 · Colorado Needle Electrode · Colorado Biomedical, Inc. · 19881990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors 1 generation forward: 3 descendants2 generations forward: 8 descendants3 generations forward: 11 descendants4 generations forward: 10 descendants5 generations forward: 1 descendant K881763 · Colorado Needle Electrode · Colorado Biomedical, Inc. · 19880+5
  1. Root · 1 generation backK881763 Colorado Needle ElectrodeColorado Biomedical, Inc. · 1988
  2. This deviceK990362 Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc. · 1999
  3. Descendant · cites it directly · 18 of its ownK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
  4. Descendant · cites it directly · 18 of its ownK031710 Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2003
  5. Descendant · 2 generations on · 15 of its ownK050885 Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation · 2005
  6. Descendant · 2 generations on · 11 of its ownK111202 Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · Recalled
  7. Descendant · 3 generations on · 9 of its ownK132703 ThunderbeatOlympus Medical Systems Corp. · 2014

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 22010: 12012: 22013: 12014: 32015: 22016: 42017: 32018: 42019: 12020: 22021: 22023: 12024: 12025: 12026: 1
2003high 4 (2016) · low 0 (2006)2026

Most influential descendants

Showing 5 of 33 · See all
  • K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010 · cites it directly18descendants
  • K031710Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2003 · cites it directly18descendants
  • K050885Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation · 2005 · 2 generations on15descendants
  • K111202Surgical Tissue Management SystemOlympus Medical Systems Corp. · 2012 · 2 generations on11descendants
  • K132703ThunderbeatOlympus Medical Systems Corp. · 2014 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K881763Colorado Needle ElectrodeColorado Biomedical, Inc.1988—
0 (this device)K990362Instrument, Ultrasonic, ScalpelEthicon Endo-Surgery, Inc.1999—
+1K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC2010—
+1K031710Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd.2003—
+2K050885Olympus Ultrasonic Surgical System SonosurgOlympus Medical Systems Corporation2005—
+2K111202Surgical Tissue Management SystemOlympus Medical Systems Corp.201210
+3K132703ThunderbeatOlympus Medical Systems Corp.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199510
199610
199710
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200520
201010
201220
201310
201430
201520
201640
201730
201840
201910
202020
202120
202310
202410
202510
202610
FIG. 1 — Lineage of K990362, 1988–2026Source: 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 GEI? 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 GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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? (8)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K983316Ultracision 5MM Instruments
Summary page 1
…Description: Ethicon Endo-Surgery, Inc 4545 Creek Road Cincinnati, Ohio 45242 Ruth Ann Wood February 5, 1999 Ultracision Harmonic Scalpel Ultracision Harmonic Scalpel K983316, K941897, K924281 Valley Labs Electrocautery Pencils K955109, K962044, K964602 Colorado Microdissection Needle K881763 Arthroc…
Ethicon Endo-Surgery, Inc.1998—
*K941897Ultracison Harmonic Scalpel HS2 Blade
Summary page 1
…on: Ethicon Endo-Surgery, Inc 4545 Creek Road Cincinnati, Ohio 45242 Ruth Ann Wood February 5, 1999 Ultracision Harmonic Scalpel Ultracision Harmonic Scalpel K983316, K941897, K924281 Valley Labs Electrocautery Pencils K955109, K962044, K964602 Colorado Microdissection Needle K881763 Arthrocare Elect…
Ultracision, Inc.1994—
*K924281Harmonic Scalpel Laparosonic Blade Accessory
Summary page 1
…con Endo-Surgery, Inc 4545 Creek Road Cincinnati, Ohio 45242 Ruth Ann Wood February 5, 1999 Ultracision Harmonic Scalpel Ultracision Harmonic Scalpel K983316, K941897, K924281 Valley Labs Electrocautery Pencils K955109, K962044, K964602 Colorado Microdissection Needle K881763 Arthrocare Electrosurgery…
Ultracision, Inc.1993—
*K955109VL2600 Handswitching Pencil with Holster
Summary page 1
…nati, Ohio 45242 Ruth Ann Wood February 5, 1999 Ultracision Harmonic Scalpel Ultracision Harmonic Scalpel K983316, K941897, K924281 Valley Labs Electrocautery Pencils K955109, K962044, K964602 Colorado Microdissection Needle K881763 Arthrocare Electrosurgery System K9715632 The Ultracision Harmonic S…
Valleylab, Inc.1995—
*K962044Valleylab Coated Electrodes
Summary page 1
…o 45242 Ruth Ann Wood February 5, 1999 Ultracision Harmonic Scalpel Ultracision Harmonic Scalpel K983316, K941897, K924281 Valley Labs Electrocautery Pencils K955109, K962044, K964602 Colorado Microdissection Needle K881763 Arthrocare Electrosurgery System K9715632 The Ultracision Harmonic Scalpel is…
Valleylab, Inc.1996—
*K964602Davis Bayonet Electrodes
Summary page 1
…Ruth Ann Wood February 5, 1999 Ultracision Harmonic Scalpel Ultracision Harmonic Scalpel K983316, K941897, K924281 Valley Labs Electrocautery Pencils K955109, K962044, K964602 Colorado Microdissection Needle K881763 Arthrocare Electrosurgery System K9715632 The Ultracision Harmonic Scalpel is a cuttin…
Valleylab, Inc.1997—
*K881763Colorado Needle Electrode
Summary page 1
…n Harmonic Scalpel Ultracision Harmonic Scalpel K983316, K941897, K924281 Valley Labs Electrocautery Pencils K955109, K962044, K964602 Colorado Microdissection Needle K881763 Arthrocare Electrosurgery System K9715632 The Ultracision Harmonic Scalpel is a cutting and coagulating surgical instrument. Th…
Colorado Biomedical, Inc.1988—
Kept off the family treeK9715632Arthrocare Electrosurgery System
Number could not be read
Summary page 1
…calpel K983316, K941897, K924281 Valley Labs Electrocautery Pencils K955109, K962044, K964602 Colorado Microdissection Needle K881763 Arthrocare Electrosurgery System K9715632 The Ultracision Harmonic Scalpel is a cutting and coagulating surgical instrument. The device sys- tem has three essential parts…

Also cleared against K983316: 1 other device →

What descends from it? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K100597Harmonic Focus ShearsEthicon Endo-Surgery, LLC201018
K031710Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd.200318
K151136Harmonic HookEthicon Endo-Surgery, LLC20161

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?

  • None of the 7 ancestors has a recall.
  • Of its descendants, K100597 (Ethicon Endo-Surgery, LLC, 2010) has gone furthest, with 18 descendants of its own.
  • 1 other device also cites its predicate K983316.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The Harmonic Scalpel is intended to cut and coagulate soft tissues.

It is to be used when bleeding control and minimal thermal injury is desired. These instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, gynecologic,

ENT (Ears, Nose, Throat), thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K983316

1 other device cites the same predicate.

  • K993868The Soundvaser Dissection SystemSound Surgical Technologies, LLC · 19992 recalls

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 GEI

The GEI category page

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  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K990362 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990362: Instrument, Ultrasonic, Scalpel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990362

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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