Chrysalis Intelligence · Product Codes · LFL

LFL · Instrument, Ultrasonic Surgical

Unknown · 29 clearances · 17 unique sponsors

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Device class
Unclassified
Regulation —
Total clearances
29
2020-02-28 → 2026-07-30
Last 12 months
2
Unique sponsors
17
Classification details
Medical specialty
Unknown
Review panel
SU
Regulation number
—
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Integra LifeSciences Corporation 6 1 2025-10-08
Ethicon Endo-Surgery, LLC 3 0 2023-02-28
Misonix, Inc. 3 1 2026-07-30
Stryker Corporation 2 0 2023-02-16
Covidien, LLC 2 0 2021-11-15
Smtp Technology Co., Ltd. 2 0 2021-09-27
Miconvey Technologies Co., Ltd. 1 0 2022-09-30
Sra Developments, Ltd. 1 0 2022-12-15
Olympus Medical Systems Corporation 1 0 2021-08-04
Katalyst Surgical, LLC 1 0 2020-06-19
Hunan Handlike Minimally Invasive Surgery Co., Ltd. 1 0 2024-06-18
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. 1 0 2022-07-18
Stryker Instruments 1 0 2025-03-24
Trice Medical, Inc. 1 0 2024-11-18
Misonix, LLC, A Bioventus Company 1 0 2023-06-23
Shanghai Saints Sages Surgical Co., Ltd. 1 0 2025-06-18
Tendonova Corporation 1 0 2022-03-08
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
76999 CPT — Low Ultrasonic surgical instruments lack a single standard code; 76999 is unlisted ultrasound procedure fallback
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-30 K261448 Misonix, LLC neXus Ultrasonic Surgical Aspirator System
2025-10-08 K251162 Integra LifeSciences Corporation CUSA® Clarity Ultrasonic Surgical Aspirator System
2025-06-18 K242894 Shanghai Saints Sages Surgical Co., Ltd. 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)
2025-03-24 K243930 Stryker Instruments Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
2024-11-18 K241700 Trice Medical, Inc. Tenex 2nd Generation System
2024-07-11 K240493 Integra LifeSciences Corporation CUSA® Clarity Ultrasonic Surgical Aspirator System
2024-06-18 K233036 Hunan Handlike Minimally Invasive Surgery Co., Ltd. Ultrasonic Surgical System
2023-07-11 K230427 Integra LifeSciences Corporation CUSA Clarity Ultrasonic Surgical Aspirator System
2023-06-23 K231117 Misonix, LLC, A Bioventus Company neXus Ultrasonic Surgical Aspirator System
2023-02-28 K221790 Ethicon Endo-Surgery, LLC HARMONIC 700 Shears
2023-02-16 K223770 Stryker Corporation Sonopet 1Q 3 7cm 1Q Large
2022-12-15 K221102 Sra Developments, Ltd. LOTUS Series 4 Enhanced Shears, LOTUS Series 5
2022-09-30 K210567 Miconvey Technologies Co., Ltd. Ultrasonic Surgical System
2022-08-22 K221835 Integra LifeSciences Corporation CUSA Clarity Ultrasonic Surgical Aspirator System
2022-07-28 K221235 Misonix, Inc. neXus Ultrasonic Surgical Aspirator System
2022-07-18 K212614 Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Ultrasonic Scalpel System
2022-07-15 K221763 Integra LifeSciences Corporation CUSA Clarity Ultrasonic Surgical Aspirator System
2022-03-08 K212049 Tendonova Corporation Oclet TDS 1000
2022-02-03 K213824 Stryker Corporation Sonopet iQ Ultrasonic Aspirator System
2021-12-13 K212060 Misonix, Inc. neXus Ultrasonic Surgical Aspirator System
2021-11-15 K212301 Covidien, LLC Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
2021-09-27 K212750 Smtp Technology Co., Ltd. Ultrasonic Surgical Aspirator System, Model: XD880B
2021-08-04 K211838 Olympus Medical Systems Corporation Ultrasonic Bipolar Generator USG-410 with accessories
2021-05-21 K211273 Ethicon Endo-Surgery, LLC Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
2021-05-21 K202299 Smtp Technology Co., Ltd. Ultrasonic Surgical Aspirator System
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence