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FDA 510(k)

HydroCision SpineJet System

K-Number: K200729 · 2020-04-16

ApplicantHydrocision, Inc.
Decision Date2020-04-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HydroCision SpineJet System is the device name listed in this FDA 510(k) record. The listed applicant is Hydrocision, Inc.. It received FDA 510(k) clearance on 2020-04-16 under 510(k) number K200729. 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 SpineJet System?

HydroCision SpineJet System is a medical device that received FDA 510(k) clearance on 2020-04-16. The listed applicant is Hydrocision, Inc.. The 510(k) number is K200729.

When did HydroCision SpineJet System receive FDA 510(k) clearance?

HydroCision SpineJet System received FDA 510(k) clearance on 2020-04-16, under 510(k) number K200729.

Who is the listed applicant for HydroCision SpineJet System?

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 SpineJet System?

The FDA product code for HydroCision SpineJet System is HRX.

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 SystemK190804HydroCision TenJet Device

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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