510(k) K251162

Device: CUSA® Clarity Ultrasonic Surgical Aspirator System
Applicant: Integra LifeSciences Corporation
510(k) number: K251162
Product code: LFL
Decision: Substantially Equivalent (SESE)
Decision date: 2025-10-08
Date received: 2025-04-15
Classification name: Instrument, Ultrasonic Surgical
Medical specialty: Unknown
Review panel: Unknown
Device class: U
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Alexandra Wells
Address: 1100 Campus Rd. Princeton NJ US 08540 08540

FDA Registration Numbers

3024490294
3024021261
3015173212
3009750704
1056553
9610612
3021599290
3009747810
3007713438
3002807314
3021970868
3009265194
8010177
8010047
3026612481
3011050570
2182291
3016096100
3017196117
3004636440
3007997036
1047843
2032112
3018094310
2011171
1319639
1221053
3003800159
3004608878
3001675293
1928237
3003724334
2183967
3001592626
3040335671
1018470
3007014520
3017636737
3013111980
1721686
1219930
3013188547
3014479313
3014932737
3015183635
3011120183
2029015
1056128
9610773
3013283620
3004111573
3006697299
3010408671
1527736
3009380063
1643817
3002808148
3004530184
2133786
3010760216
2183715
1061124
1650907
3015612252
3015967359
2435119
9616696
3003418325
3005646850
2030598
1717344
3009941480
3030153385
1722139
8043817
1417592
3011989923
3011024991
2648666
9710649

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code LFL

510(k)	Device	Applicant	Decision date
K242894	SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)	Shanghai Saints Sages Surgical Co., Ltd.	2025-06-18
K243930	Sonopet iQ Ultrasonic Aspirator System (5500-050-000)	Stryker Instruments	2025-03-24
K241700	Tenex 2nd Generation System	Trice Medical, Inc.	2024-11-18
K240493	CUSA® Clarity Ultrasonic Surgical Aspirator System	Integra LifeSciences Corporation	2024-07-11
K233036	Ultrasonic Surgical System	Hunan Handlike Minimally Invasive Surgery Co., Ltd.	2024-06-18
K230427	CUSA Clarity Ultrasonic Surgical Aspirator System	Integra LifeSciences Corporation	2023-07-11
K231117	neXus Ultrasonic Surgical Aspirator System	Misonix, LLC, A Bioventus Company	2023-06-23
K221790	HARMONIC 700 Shears	Ethicon Endo-Surgery, LLC	2023-02-28
K223770	Sonopet 1Q 3 7cm 1Q Large	Stryker Corporation	2023-02-16
K221102	LOTUS Series 4 Enhanced Shears, LOTUS Series 5	Sra Developments, Ltd.	2022-12-15
K210567	Ultrasonic Surgical System	Miconvey Technologies Co., Ltd.	2022-09-30
K221835	CUSA Clarity Ultrasonic Surgical Aspirator System	Integra LifeSciences Corporation	2022-08-22
K221235	neXus Ultrasonic Surgical Aspirator System	Misonix, Inc.	2022-07-28
K212614	Ultrasonic Scalpel System	Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.	2022-07-18
K221763	CUSA Clarity Ultrasonic Surgical Aspirator System	Integra LifeSciences Corporation	2022-07-15