510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Ultrasonic Straight/Ultrasonic Knife/Ultrasonic Ring Currette

K020220510(k) TraditionalCleared Aug 23, 2002213-day reviewClass URecalls 1

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

Synergetics, Inc. · LFL Instrument, Ultrasonic Surgical

Cleared on Aug 23, 2002 after a 213-day review. The FDA summary names its predicate without a number. 30 later devices descend from it. It has been recalled once.

Decided
Aug 23, 2002
Review
213 days
Class
Class U
Product code
LFL
Recalls
1
Predicates
0

30 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2007: 1 descendant cleared2009: 1 descendant cleared2014: 2 descendants cleared2006: 1 descendant cleared2008: 1 descendant cleared2011: 2 descendants cleared2019: 2 descendants cleared2021: 3 descendants cleared2018: 2 descendants cleared2016: 1 descendant cleared2012: 1 descendant cleared2015: 1 descendant cleared2022: 3 descendants cleared2017: 1 descendant cleared2024: 2 descendants cleared2020: 1 descendant cleared2025: 1 descendant cleared2023: 2 descendants cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK020220 Ultrasonic Straight/Ultrasonic Knife/Ultrasonic Ring CurretteSynergetics, Inc. · 2002
  2. Descendant · cites it directly · 29 of its ownK051947 Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP · 2005
  3. Descendant · cites it directly · 17 of its ownK071669 Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc. · 2007
  4. Descendant · 2 generations on · 16 of its ownK081459 Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 2008 · Recalled
  5. Descendant · 2 generations on · 14 of its ownK141668 Cusa Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2014
  6. Descendant · 3 generations on · 11 of its ownK161882 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2016 · Recalled

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 12008: 12009: 12011: 22012: 12014: 22015: 12016: 12017: 12018: 22019: 22020: 12021: 32022: 32023: 22024: 22025: 12026: 1
2005high 3 (2021) · low 0 (2010)2026

Most influential descendants

Showing 5 of 30 · See all
  • K051947Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP · 2005 · cites it directly29descendants
  • K071669Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc. · 2007 · cites it directly17descendants
  • K081459Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 2008 · 2 generations on16descendants
  • K141668Cusa Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2014 · 2 generations on14descendants
  • K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2016 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020220Ultrasonic Straight/Ultrasonic Knife/Ultrasonic Ring CurretteSynergetics, Inc.2002—
+1K051947Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP2005—
+1K071669Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc.2007—
+2K081459Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc.20084
+2K141668Cusa Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation2014—
+3K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation20162

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
200810
200910
201120
201210
201420
201510
201610
201710
201820
201920
202010
202130
202230
202320
202420
202510
202610
FIG. 1 — Lineage of K020220, 2002–2026Source: 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? (1)

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
*—CUSA Excel Ultrasonic Surgical Aspirator
Named without a submission number
—

What descends from it? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K051947Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP200529
K071669Integra Selector Ultrasonic Surgical Aspirator System with Bone TipIntegra Radionics, Inc.200717

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 22, 2016Class IIZ-1378-2016Mixed-up of materials/componentsThe Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembly included in the packaging is the incorrect size. Risk to Health: If the Tip Sleeve Assembly does not fit the Spetzler Claw" Tip, a surgical…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K051947 (Radionics, A Division of Tyco Healthcare Group LP, 2005) has gone furthest, with 29 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—

What is it indicated for?

Synergetics SonotomeTMUltrasonic Aspirator Tips are intended for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable, including:

Neurosurgery

Gastrointestinal and Affiliated Organ Surgery

Urological Surgery

Plastic and Reconstructive Surgery

General Surgery

Orthopedic Surgery

Gynecological Surgery

Thoracic Surgery

Laparoscopic Surgery

Thoracoscopic Surgery

Indications for use as stated in the FDA summary.

More from Synergetics, Inc.

16 FDA decisions under this applicant name. See the company

  • K121426Aynergetics Disposable Spetzler-Malis Standard Bipolar ForcepsSynergetics, Inc. · 201219 recalls
  • K121675VersavitSynergetics, Inc. · 20124 recalls
  • K113857Synergetics Directional Endoocular Laser ProbeSynergetics, Inc. · 2012
  • K110924Disposable Spetzler-Malis Dual Irrigating Bipolar ForcepsSynergetics, Inc. · 20113 recalls
  • K091441Synergetics Adjustable Gas Pressurized Infusion (Agpi) Tube SetSynergetics, Inc. · 2009

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/K020220 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020220: Ultrasonic Straight/Ultrasonic Knife/Ultrasonic Ring Currette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020220

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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