Pristine Scope— 510(k) K183165

Substantially Equivalent

Pristine Surgical

FDA 510(k) clearance K183165 for Pristine Scope, Substantially Equivalent on 2019-01-16. Applicant: Pristine Surgical.

Clearance details

Applicant: Pristine Surgical
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2018-11-15
Decision date: 2019-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.