FDA 510(k)

Pristine Scope

K-Number: K183165 · 2019-01-16

Decision Date2019-01-16

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Pristine Scope is a medical device manufactured by Pristine Surgical. It received FDA 510(k) clearance on 2019-01-16 under approval number K183165. 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 Scope?

Pristine Scope is a medical device that received FDA 510(k) clearance on 2019-01-16. It is manufactured by Pristine Surgical. The 510(k) number is K183165.

When was Pristine Scope approved by the FDA?

Pristine Scope received FDA 510(k) clearance on 2019-01-16, under approval number K183165.

What company makes Pristine Scope?

Pristine Scope is manufactured by Pristine Surgical.

What is the FDA product code for Pristine Scope?

The FDA product code for Pristine Scope is HRX.

Other Devices by Pristine Surgical

K193161Pristine Scope K223244Pristine Arthroscopic Visualization System

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

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