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FDA 510(k)

SpineSite Endoscope System

K-Number: K241990 · 2025-07-30

ApplicantHydrocision, Inc.
Decision Date2025-07-30
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SpineSite Endoscope 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 2025-07-30 under 510(k) number K241990. 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 SpineSite Endoscope System?

SpineSite Endoscope System is a medical device that received FDA 510(k) clearance on 2025-07-30. The listed applicant is Hydrocision, Inc.. The 510(k) number is K241990.

When did SpineSite Endoscope System receive FDA 510(k) clearance?

SpineSite Endoscope System received FDA 510(k) clearance on 2025-07-30, under 510(k) number K241990.

Who is the listed applicant for SpineSite Endoscope 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 SpineSite Endoscope System?

The FDA product code for SpineSite Endoscope 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.

K200729HydroCision SpineJet 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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