Sonex health 510k

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August undefined, 2024

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. 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 Company Profile - Craft

WebSonex Health brings together a well-respected and experienced team of individuals who know how to create, develop and market medical technologies that can change the lives of millions of patients. Now, working as one, we’re tapping into the power of ultrasound guidance and innovation to transform the patient experience and improve healthcare. 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 ... inax bf-wm145tsg

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION …

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 … WebHeader placeholder lorem ipsum dolor sit amet, consectetur adipiscing elit. WebSonex Health Medical Equipment Manufacturing Eagan, Minnesota 2,151 followers We believe in the transformative power of ultrasound guided procedures for Carpal Tunnel … inches wg

Sonex Health - Funding, Financials, Valuation & Investors

510(k) Clearances FDA - U.S. Food and Drug Administration

WebVice 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 … 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 ... inches weight loss chartWeb10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA inax bf4646tcr水栓切換え弁

"WebK191352 - Page 1 of 25 . Food and Drug Administration . 10903 New Hampshire Avenue . Silver Spring, MD 20993-0002 . www.fda.gov . 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION " - Sonex health 510k

Sonex health 510k

WebFounded Date 2014. Founders Aaron Keenan, Darryl Barnes, Jay Smith. Operating Status Active. Last Funding Type Venture - Series Unknown. Legal Name Sonex Health, Inc. … WebSep 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 …

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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 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)

WebFunding. 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 … 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 ... About Sonex …

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 … WebAug 9, 2024 · Aug 9th, 2024. SONEX HEALTH ANNOUNCES FIRST PATIENT ENROLLED IN U.S. CLINICAL STUDY TO TREAT CARPAL TUNNEL SYNDROME WITH ULTRASOUND …

WebThe SX-One MicroKnife® is the ultra-low profile surgical instrument designed to minimize surgical trauma which is associated with a faster recovery in carpal...

WebNov 18, 2024 · Sonex Health has developed the SX-One MicroKnife with Meerkat Technology® to treat carpal tunnel syndrome in a novel fashion. This innovation allows … inax bl-s93133WebVice 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 her role. Prior to joining Sonex Health, Ms. Grabowski was with Boston Scientific, where she served as Director, Global Clinical Infrastructure & Programs. inax bc-110stuWebAug 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 ... inax by-1216WebMar 30, 2024 · 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 ... inax bf-wm646tsg 300WebJan 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. inches with fractionsWebFeb 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 ... inax by-1418lbefWebSonex'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. … inches with apostrophe