STERILE STORM (R) OPERATING KIT— 510(k) K111001

Substantially Equivalent

Intelligent Orthopaedics, Ltd.

FDA 510(k) clearance K111001 for STERILE STORM (R) OPERATING KIT, Substantially Equivalent on 2011-05-17. Applicant: Intelligent Orthopaedics, Ltd..

Clearance details

Applicant: Intelligent Orthopaedics, Ltd.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2011-04-11
Decision date: 2011-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Stoke On Trent, Staffordshire, GB

Download summary PDF View on FDA.gov ↗

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.