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

FDA 510(k)

Pristine Arthroscopic Visualization System

K-Number: K223244 · 2022-12-21

ApplicantPristine Surgical
Decision Date2022-12-21
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pristine Arthroscopic Visualization System is a medical device manufactured by Pristine Surgical. It received FDA 510(k) clearance on 2022-12-21 under approval number K223244. 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 Pristine Arthroscopic Visualization System?

Pristine Arthroscopic Visualization System is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Pristine Surgical. The 510(k) number is K223244.

When was Pristine Arthroscopic Visualization System approved by the FDA?

Pristine Arthroscopic Visualization System received FDA 510(k) clearance on 2022-12-21, under approval number K223244.

What company makes Pristine Arthroscopic Visualization System?

Pristine Arthroscopic Visualization System is manufactured by Pristine Surgical.

What is the FDA product code for Pristine Arthroscopic Visualization System?

The FDA product code for Pristine Arthroscopic Visualization System is HRX.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED NCT07275723 A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Body Parts (Non-Central Nervous System) Lesions ACTIVE_NOT_RECRUITING

Other Devices by Pristine Surgical

K183165Pristine Scope K193161Pristine Scope

Related Devices (Code: HRX)

K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation K161878PORTAGE SystemBaylis Medical Company, Inc. K162475mi-eye 2, mi-eye 2 monitorTrice Medical K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaProsurg, Inc. K160249ULTRA TelescopesOlympus Winter & Ibe GmbH K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingStryker Corporation

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.

↑