510(k) Report

510(k) · Cleared

Cleared

Cusa Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical Aspirator System

K090864510(k) TraditionalCleared May 8, 200939-day reviewClass U

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

Integra Radionics, Inc. · LFL Instrument, Ultrasonic Surgical

Cleared on May 8, 2009 as substantially equivalent to K981262 (Valleylab, Inc., 1998) and 2 other predicates after a 39-day review. Its family tree reaches back 5 generations to 1988.

Decided
May 8, 2009
Review
39 days
Class
Class U
Product code
LFL
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K884413 (1988). 16 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2007: 1 other ancestor2002: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1992: 1 other ancestor1980: 1 other ancestor2001: 2 other ancestors1993: 1 other ancestor1990: 1 other ancestorK884413 · Cusa System 200H Ultrasonic Surgical Aspirator · Valleylab, Inc. · 1988K981262 · Cusa Excel Ultrasonic Surgical Aspirator System · Valleylab, Inc. · 1998 · recalledK021989 · Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3 · Integra Neurosciences · 2002 · recalledK042277 · Selector Quantum Ultrasonic Aspirator System · Integra Neurosciences, Ltd. · 2004K081459 · Cusa Selector NXT Ultrasonic Tissue Ablation System · Integra Radionics, Inc. · 2008 · recalled1980198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 6 other ancestors3 generations back: 4 other ancestors K081459 · Cusa Selector NXT Ultrasonic Tissue Ablation System · Integra Radionics, Inc. · 2008 · recalledK042277 · Selector Quantum Ultrasonic Aspirator System · Integra Neurosciences, Ltd. · 2004K021989 · Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3 · Integra Neurosciences · 2002 · recalledK981262 · Cusa Excel Ultrasonic Surgical Aspirator System · Valleylab, Inc. · 1998 · recalledK884413 · Cusa System 200H Ultrasonic Surgical Aspirator · Valleylab, Inc. · 1988−50
  1. Root · 5 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
  2. 4 generations backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
  3. 3 generations backK021989 Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 2002 · Recalled
  4. 2 generations backK042277 Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd. · 2004
  5. 1 generation backK081459 Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 2008 · Recalled
  6. This deviceK090864 Cusa Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical…Integra Radionics, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K884413Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc.1988—
−4K981262Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc.19983
−3K021989Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences20022
−2K042277Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd.2004—
−1K081459Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc.20084
0 (this device)K090864Cusa Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical Aspirator…Integra Radionics, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199010
199210
199310
199410
199510
200120
200210
200510
200710
FIG. 1 — Lineage of K090864, 1988–2009Source: 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? (3)

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
*K981262Cusa Excel Ultrasonic Surgical Aspirator System
Summary page 1
…cate devices. The technological characteristics are similar to those found in the following predicate devices: CUSA EXCEL Ultrasonic Surgical Aspirator System via 510(k) K981262 on July, 6, 1998; CUSA EXCEL Ultrasonic Surgical Aspirator System with Bone Tip cleared via 510(k) K051947 on August 22, 2005 and…
Valleylab, Inc.19983
*K051947Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone
Summary page 1
…es: CUSA EXCEL Ultrasonic Surgical Aspirator System via 510(k) K981262 on July, 6, 1998; CUSA EXCEL Ultrasonic Surgical Aspirator System with Bone Tip cleared via 510(k) K051947 on August 22, 2005 and CUSA Selector NXT Ultrasonic Tissue Ablation System cleared via 510(k) K08 1459 on August 13, 2008.…
Radionics, A Division of Tyco Healthcare Group LP2005—
*K081459Cusa Selector NXT Ultrasonic Tissue Ablation System
Summary page 1
…trasonic Surgical Aspirator System with Bone Tip cleared via 510(k) K051947 on August 22, 2005 and CUSA Selector NXT Ultrasonic Tissue Ablation System cleared via 510(k) K08 1459 on August 13, 2008. Page 1 of 2 The CUSA Shear Tip is an additional tip…
Integra Radionics, Inc.20084

Also cleared against K981262: 10 other devices →

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 21 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
  • 5 of the 16 ancestors have a recall of any class.
  • 10 other devices also cite its predicate K981262.

How does its category compare?

All LFL devices

LFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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 CUSA Shear Tip, an accessory of the CUSA EXcel Ultrasonic Surgical Aspirator System, is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft 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 and Thoracoscopic surgery.

Indications for use as stated in the FDA summary.

Also cleared against K981262

10 other devices cite the same predicate.

  • K141668Cusa Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2014
  • K141674Cusa Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 20141 recall
  • K102258Cusa NXT Extended Length TipIntegra Radionics, Inc. · 2011
  • K051947Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP · 2005
  • K042277Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd. · 2004
  • K041566Sonosurg Ultrasonic Surgical SystemAomori Olympus Co., Ltd. · 2004

More from Integra Radionics, Inc.

10 FDA decisions under this applicant name. See the company

  • K102258Cusa NXT Extended Length TipIntegra Radionics, Inc. · 2011
  • K100096Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc. · 2010
  • K100417Xknife 5Integra Radionics, Inc. · 20101 recall
  • K083414Radionics Xknife HDRT SystemIntegra Radionics, Inc. · 2009
  • K081459Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 20084 recalls

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/K090864 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090864: Cusa Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical Aspirator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090864

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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