Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

C Scope Visualization System

K-Number: K203526 · 2021-01-12

ApplicantCit Ortho
Decision Date2021-01-12
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

C Scope Visualization System is the device name listed in this FDA 510(k) record. The listed applicant is Cit Ortho. It received FDA 510(k) clearance on 2021-01-12 under 510(k) number K203526. 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 C Scope Visualization System?

C Scope Visualization System is a medical device that received FDA 510(k) clearance on 2021-01-12. The listed applicant is Cit Ortho. The 510(k) number is K203526.

When did C Scope Visualization System receive FDA 510(k) clearance?

C Scope Visualization System received FDA 510(k) clearance on 2021-01-12, under 510(k) number K203526.

Who is the listed applicant for C Scope Visualization System?

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

What is the FDA product code for C Scope Visualization System?

The FDA product code for C Scope Visualization System is HRX.

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

View on FDA Database →

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

↑