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 a medical device manufactured by Hydrocision, Inc.. It received FDA 510(k) clearance on 2025-07-30 under approval 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. It is manufactured by Hydrocision, Inc.. The 510(k) number is K241990.
When was SpineSite Endoscope System approved by the FDA?
SpineSite Endoscope System received FDA 510(k) clearance on 2025-07-30, under approval number K241990.
What company makes SpineSite Endoscope System?
SpineSite Endoscope System is manufactured by Hydrocision, Inc..
What is the FDA product code for SpineSite Endoscope System?
The FDA product code for SpineSite Endoscope System is HRX.
Related Clinical Trials
Other Devices by Hydrocision, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.