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)

Pristine Scope

K-Number: K183165 · 2019-01-16

ApplicantPristine Surgical
Decision Date2019-01-16
Product CodeHRX
Advisory CommitteeOR
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 2019-01-16 under 510(k) 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. The listed applicant is Pristine Surgical. The 510(k) number is K183165.

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

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

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 HRX.

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 SystemK193161Pristine Scope

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.

↑