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FDA 510(k)

HydroCision TenJet Device

K-Number: K190804 · 2019-06-05

ApplicantHydrocision, Inc.
Decision Date2019-06-05
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HydroCision TenJet Device is the device name listed in this FDA 510(k) record. The listed applicant is Hydrocision, Inc.. It received FDA 510(k) clearance on 2019-06-05 under 510(k) number K190804. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HydroCision TenJet Device?

HydroCision TenJet Device is a medical device that received FDA 510(k) clearance on 2019-06-05. The listed applicant is Hydrocision, Inc.. The 510(k) number is K190804.

When did HydroCision TenJet Device receive FDA 510(k) clearance?

HydroCision TenJet Device received FDA 510(k) clearance on 2019-06-05, under 510(k) number K190804.

Who is the listed applicant for HydroCision TenJet Device?

The FDA 510(k) record lists Hydrocision, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HydroCision TenJet Device?

The FDA product code for HydroCision TenJet Device is HRX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03487250Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery SystemCOMPLETED

Other records listing Hydrocision, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241990SpineSite Endoscope SystemK200729HydroCision SpineJet System

Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)K250795PUREVUE™ FMSW.O.M. World of Medicine GmbHK252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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