510(k) Report

510(k) · Cleared

Cleared

Sonosurg Ultrasonic Surgical System

K041566510(k) TraditionalCleared Sep 8, 200490-day reviewClass U

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

Aomori Olympus Co., Ltd. · LFL Instrument, Ultrasonic Surgical

Cleared on Sep 8, 2004 as substantially equivalent to K032066 (The Olympus Optical Co., 2003) and 8 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1980.

Decided
Sep 8, 2004
Review
90 days
Class
Class U
Product code
LFL
Recalls
None
Predicates
9

Its longest line of descent runs back 5 generations to K801623 (1980). 33 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 3 other ancestors2001: 3 other ancestors2000: 1 other ancestor1998: 2 other ancestors1999: 2 other ancestors1995: 4 other ancestors1994: 3 other ancestors1992: 1 other ancestor1991: 2 other ancestors1988: 3 other ancestors1997: 1 other ancestor1996: 1 other ancestor1993: 2 other ancestorsK801623 · Cavitron Ultrasonic Surg. Aspir. Cusa · Cavitron Corp. · 1980K962952 · Olympus Ultrasonic Surgical System (Usu) · Olympus Optical, Co. · 1996K972114 · Olympus Sonosurg System · The Olympus Optical Co. · 1998K021962 · Olympus Ultrasonic Surgical System · The Olympus Optical Co. · 2003K032066 · Sonosurg System · The Olympus Optical Co. · 2003198019851990199520002005
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 11 other ancestors3 generations back: 11 other ancestors K032066 · Sonosurg System · The Olympus Optical Co. · 2003K021962 · Olympus Ultrasonic Surgical System · The Olympus Optical Co. · 2003K972114 · Olympus Sonosurg System · The Olympus Optical Co. · 1998K962952 · Olympus Ultrasonic Surgical System (Usu) · Olympus Optical, Co. · 1996K801623 · Cavitron Ultrasonic Surg. Aspir. Cusa · Cavitron Corp. · 1980−50
  1. Root · 5 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
  2. 4 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
  3. 3 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
  4. 2 generations backK021962 Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003
  5. 1 generation backK032066 Sonosurg SystemThe Olympus Optical Co. · 2003
  6. This deviceK041566 Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K801623Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp.1980—
−4K962952Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co.1996—
−3K972114Olympus Sonosurg SystemThe Olympus Optical Co.1998—
−2K021962Olympus Ultrasonic Surgical SystemThe Olympus Optical Co.2003—
−1K032066Sonosurg SystemThe Olympus Optical Co.2003—
0 (this device)K041566Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198830
199120
199210
199320
199430
199540
199610
199710
199820
199920
200010
200130
200330
FIG. 1 — Lineage of K041566, 1980–2004Source: 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? (9)

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
*K032066Sonosurg System
Summary page 2
…-ass Product SonoSurg System Code #1(032066 Olympus NWo -Classification 80-LFL ___ ___ __Co orati…
The Olympus Optical Co.2003—
*K000095Olympus Sonosurg Trocar XT3900 System
Summary page 2
…66), CUSA EXcel Ultrasonic Surgical Aspirator System (#1(981262), SONOPET UST-2001 Ultra Surgical Aspirator (#K01 0309) and Ultrasonic Surgical System (#K(962952, #1(000095, #1(021 962. #K03171 0, 2 #K031523, #K031305), SonoSurg U…
The Olympus Optical Co.2000—
*K021962Olympus Ultrasonic Surgical SystemThe Olympus Optical Co.2003—
*K031710Olympus Ultrasonic Surgical System
Summary page 2
…sonic Surgical Aspirator System (#1(981262), SONOPET UST-2001 Ultra Surgical Aspirator (#K01 0309) and Ultrasonic Surgical System (#K(962952, #1(000095, #1(021 962. #K03171 0, 2 #K031523, #K031305), SonoSurg Ultrasonic Surgical Syst…
Aomori Olympus Co., Ltd.2003—
*K031523Olympus Ultrasonic Surgical System
Summary page 3
…tor (#K01 0309) and Ultrasonic Surgical System (#K(962952, #1(000095, #1(021 962. #K03171 0, 2 #K031523, #K031305), SonoSurg Ultrasonic Surgical System does not incorporate any significant changes in the intended use, method of opera…
Aomori Olympus Co., Ltd.2003—
*K031305Olympus Ultrasonic Surgical System
Summary page 3
…1 0309) and Ultrasonic Surgical System (#K(962952, #1(000095, #1(021 962. #K03171 0, 2 #K031523, #K031305), SonoSurg Ultrasonic Surgical System does not incorporate any significant changes in the intended use, method of operation, mate…
Olympus Optical Co., Ltd.2003—
*K981262Cusa Excel Ultrasonic Surgical Aspirator System
Summary page 2
…1 0 Corporation #1(031523 #1(031305 CUSA Excel Ultrasonic Surgical #1K981262 Valleyla-b No Cla;ssification 80-LFL Aspirator System…
Valleylab, Inc.19983
*K010309Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator
Summary page 2
…on 80-LFL Aspirator System ~~~~~~~~~84-LBK SONOPET UST-2001 Uftra #-iK010309 Miwatec No Classification 80-LFL Surgical Aspirator ---- 25 (1ymu Ultrasonic…
Mutoh America Co., Ltd.20014
*K962952Olympus Ultrasonic Surgical System (Usu)
Summary page 2
…em (#1(032066), CUSA EXcel Ultrasonic Surgical Aspirator System (#1(981262), SONOPET UST-2001 Ultra Surgical Aspirator (#K01 0309) and Ultrasonic Surgical System (#K(962952, #1(000095, #1(021 962. #K03171 0, 2 #K031523, #K031305),…
Olympus Optical, Co.1996—

What descends from it?

No later submission names this one as a predicate yet.

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 24 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
  • 2 of the 33 ancestors have a recall of any class.

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 SonoSurg Olympus Ultrasonic Surgical System is indicated for use in surgical procedure in neurosurgery where dissection, fragmentation, emulsification and aspiration of soft tissue are desirable.

This system consists of the SonoSurg Generator (SonoSurg-G2 set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducer (SonoSurg-T2L-MS), and SonoSurg ultrasonic surgical instruments, and is designed to be used with a separate surgical suction source.

Do not use this system for any purpose other than its intended use.

Indications for use as stated in the FDA summary.

More from Aomori Olympus Co., Ltd.

7 FDA decisions under this applicant name. See the company

  • K042160Sonosurg TrocarAomori Olympus Co., Ltd. · 2005
  • K033333Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-BAomori Olympus Co., Ltd. · 2003
  • K031523Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2003
  • K031710Olympus Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2003
  • K021672Pancreatic Drainage TubeAomori Olympus Co., Ltd. · 2003

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/K041566 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041566: Sonosurg Ultrasonic Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041566

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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