Intra-Operative Positioning System (IOPS®)— 510(k) K243842

Substantially Equivalent

Centerline Biomedical, Inc.

FDA 510(k) clearance K243842 for Intra-Operative Positioning System (IOPS®), Substantially Equivalent on 2025-03-06. Applicant: Centerline Biomedical, Inc..

Clearance details

Applicant: Centerline Biomedical, Inc.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2024-12-13
Decision date: 2025-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.