Pristine Scope
K-Number: K193161 · 2020-04-21
ApplicantPristine Surgical
Decision Date2020-04-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Pristine Scope is a medical device manufactured by Pristine Surgical. It received FDA 510(k) clearance on 2020-04-21 under approval number K193161. The device is classified under product code GCJ. It was reviewed by the GU 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 2020-04-21. It is manufactured by Pristine Surgical. The 510(k) number is K193161.
When was Pristine Scope approved by the FDA?
Pristine Scope received FDA 510(k) clearance on 2020-04-21, under approval number K193161.
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 GCJ.
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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.