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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Pristine Surgical. It received FDA 510(k) clearance on 2020-04-21 under 510(k) 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. The listed applicant is Pristine Surgical. The 510(k) number is K193161.

When did Pristine Scope receive FDA 510(k) clearance?

Pristine Scope received FDA 510(k) clearance on 2020-04-21, under 510(k) number K193161.

Who is the listed applicant for Pristine Scope?

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

What is the FDA product code for Pristine Scope?

The FDA product code for Pristine Scope is GCJ.

Other records listing Pristine Surgical as applicant

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.

K223244Pristine Arthroscopic Visualization SystemK183165Pristine Scope

Related Devices (Code: GCJ)

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.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

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.

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