PARCUS PEEK CF PUSH-IN SUTURE ANCHOR— 510(k) K102162

Substantially Equivalent

Parcus Medical, LLC

FDA 510(k) clearance K102162 for PARCUS PEEK CF PUSH-IN SUTURE ANCHOR, Substantially Equivalent on 2010-11-10. Applicant: Parcus Medical, LLC.

Clearance details

Applicant: Parcus Medical, LLC
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2010-08-02
Decision date: 2010-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sturgeon Bay, WI, US

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.