EasyClip Xpress— 510(k) K162321

Substantially Equivalent

Restore Surgical, LLC Dba Instratek

FDA 510(k) clearance K162321 for EasyClip Xpress, Substantially Equivalent on 2017-02-10. Applicant: Restore Surgical, LLC Dba Instratek.

Clearance details

Applicant: Restore Surgical, LLC Dba Instratek
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2016-08-19
Decision date: 2017-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.