510(k) K221102

Device: LOTUS Series 4 Enhanced Shears, LOTUS Series 5
Applicant: Sra Developments, Ltd.
510(k) number: K221102
Product code: LFL
Decision: Substantially Equivalent (SESE)
Decision date: 2022-12-15
Date received: 2022-04-14
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: Phillipa Frewin
Address: Bremridge House Ashburton GB TQ13 7JX TQ13 7JX

FDA Registration Numbers

3013111980
3002808148
1527736
3013283620
3026612481
9613895
1061124
3009350690
2133786
3001592626
3012507533
3009941480
3005646850
3015540957
2183744
3013188547
1018470
3003724334
3011024991
3021970868
3024490294
3007713438
2183715
3011050570
3041274936
3013557562
9610612
1721676
3009116370
3017636737
3002807314
3017196117
3006697299
3010760216
3011120183
8010177
3004636440
3004530184
3001675293
3014279513
3025663926
3015173212
3030153385
3007225330
2029015
2183967
1417592
1928237
1724474
1319639
3010188783
1056553
3015183635
3021599290
1722139
3007997036
3040335671
9614641
1717344
1221053
3010141593
3010432890
1722447
3012494290
2182291
3024021261
3003800159
2032112
3021194552
8043817
3015612252
3011823740
2030598
1047843
1650907
1643817
3009380063
8010047
1721686
3004608878

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code LFL

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K251162	CUSA® Clarity Ultrasonic Surgical Aspirator System	Integra LifeSciences Corporation	2025-10-08
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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
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