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510(k) Data Aggregation
K Number
K223244Device Name
Pristine Arthroscopic Visualization System
Manufacturer
Date Cleared
2022-12-21
(62 days)
Product Code
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
Pristine Surgical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pristine Arthroscopic Visualization System is an endoscopic device introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. The Pristine Arthroscopic Visualization System is indicated for use in arthroscopic procedures performed in the hip, knee and shoulder.
Device Description
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K Number
K193161Device Name
Pristine Scope
Manufacturer
Date Cleared
2020-04-21
(158 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Pristine Surgical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pristine Scope has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
Device Description
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K Number
K183165Device Name
Pristine Scope
Manufacturer
Date Cleared
2019-01-16
(62 days)
Product Code
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
Pristine Surgical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pristine Scope is an endoscopic device into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. The Pristine Scope is indicated for use in arthroscopic procedures performed in the hip, knee and shoulder.
Device Description
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