Sonex health 510k

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August undefined, 2024

WebSonex Health Medical Equipment Manufacturing Eagan, Minnesota 2,151 followers We believe in the transformative power of ultrasound guided procedures for Carpal Tunnel … WebYou can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following format:

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WebNov 17, 2024 · Sonex's first device, the SX-One MicroKnife ®, is FDA 510k cleared and is the first major technological advance in treating Carpal Tunnel Syndrome (CTS) in 20 years. WebAug 31, 2024 · Section 510 (k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is ... philipp schittek

Sonex Health Company Profile - Craft

WebNov 17, 2024 · Sonex's first device, the SX-One MicroKnife ®, is FDA 510k cleared and is the first major technological advance in treating Carpal Tunnel Syndrome (CTS) in 20 years. … WebSonex Health is a company engaged in the development of minimally invasive procedural solutions. It offers SX-One MicroKnife, a surgical device that enables physicians to … WebSonex Health, Inc. SX-One MicroKnife® SECTION 5: 510(K) SUMMARY Sponsor/Submitter: Sonex Health 11 1 st Avenue SW, Suite 202 Rochester, MN 55902 . Contact Person: Aaron … trust books login

Sonex Health Micro-invasive Carpal Tunnel Release (CTR

WebMar 10, 2024 · You can send an eSTAR or eCopy to submit your 510 (k). After you submit your 510 (k) to the FDA, and when the FDA receives the 510 (k) submission, it assigns the submission a unique control number ... WebSonex's first device, the SX-One MicroKnife®, is FDA 510k cleared and is the first major technological advance in treating Carpal Tunnel Syndrome (CTS) in 20 years. … philipp schirmerWebFunding. Sonex Health has raised a total of $30.2M in funding over 5 rounds. Their latest funding was raised on Jan 25, 2024 from a Venture - Series Unknown round. Sonex Health is funded by 3 investors. Horizon Technology Finance and … philipp schledorn

"WebInstructions For Use and Safety Information. Introducing UltraGuideCTR™, formerly known as the SX-One MicroKnife. UltraGuideCTR is the same device with the same intended use, … " - Sonex health 510k

Sonex health 510k

Sonex Health - Overview, News & Competitors ZoomInfo.com

WebSonex Health. Hospitals & Physicians Clinics · Minnesota, United States · <25 Employees . Founded in 2014, Sonex Health's mission is to be the world leader in ultrasound guided surgery by delivering physicians innovative therapies that reduce invasiveness, improve safety, and reduce the cost of care. WebAug 9, 2024 · Sonex Health and The Institute of Advanced Ultrasound Guided Procedures today announced enrollment of the first patient in the Trial of Ultrasound Guided Carpal Tunnel Release (CTR) Versus ...

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WebMar 10, 2024 · You can send an eSTAR or eCopy to submit your 510 (k). After you submit your 510 (k) to the FDA, and when the FDA receives the 510 (k) submission, it assigns the … WebPhysicians. Learn about minimally invasive techniques for carpal tunnel release and trigger finger release using real-time ultrasound guidance. Benefits include: 4,9,16-18. Perform …

WebFeb 22, 2024 · Sonex Health, a leader in the ultrasound-guided treatment of common orthopedic syndromes affecting the extremities, including entrapment neuropathies and tendinopathies, today announced the ... WebHeader placeholder lorem ipsum dolor sit amet, consectetur adipiscing elit.

WebApr 10, 2024 · 510 (k) Premarket Notification. FDA Home. Medical Devices. Databases. A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513 (i) (1) (A) FD&C Act) that is not subject to premarket approval. WebThe following data is part of a premarket notification filed by Sonex Health, Inc. with the FDA for Sx-one Microknife. ... Device ID: K192873: 510k Number: K192873: Device Name: SX-One MicroKnife: Classification: Orthopedic Manual Surgical Instrument: Applicant: Sonex Health, Inc. 11 1st Ave SW Rochester, MN 55902 : Contact: Aaron Keenan ...

WebMar 20, 2024 · Sonex Health was founded in 2014 and raised a seed round that same year. After a few years of product development, the SX-One MicroKnife was used to perform the first procedure in February 2024. trustbound grcWebSep 17, 2014 · Description. Developer of an ultra-low profile surgical instrument designed to minimize surgical trauma which is associated with a faster recovery in carpal tunnel … trustboundWebThe following data is part of a premarket notification filed by Sonex Health, Inc. with the FDA for Sx-one Microknife. ... Device ID: K192873: 510k Number: K192873: Device Name: SX … philipp schlote harsumWebMar 10, 2024 · CDRH-Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993. Content current as of: 10/03/2024. Premarket Notification 510(k) trust box widgetWebAug 31, 2024 · Section 510 (k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device … trustboy scriptWebJan 14, 2024 · Barnes explained that Sonex Health’s mission is to be the leader in ultrasound-guided surgery and to equip physicians with therapies that reduce invasiveness, improve safety, and reduce the cost of care. Sonex Health provides the least invasive and safest way to perform carpal tunnel release surgery with the fastest recovery. trust bootlegsWebVice President, Clinical Affairs. Ms. Grabowski joined Sonex Health in January of 2024, bringing more than 25 years of extensive clinical operations and leadership experience to … trustbox backup