Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula— 510(k) K152511

Substantially Equivalent

Prosurg, Inc.

FDA 510(k) clearance K152511 for Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula, Substantially Equivalent on 2016-07-11. Applicant: Prosurg, Inc..

Clearance details

Applicant: Prosurg, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2015-09-02
Decision date: 2016-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

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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.