13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)— 510(k) K162453

Substantially Equivalent

Pan Medical , Ltd.

FDA 510(k) clearance K162453 for 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex), Substantially Equivalent on 2016-11-01. Applicant: Pan Medical , Ltd..

Clearance details

Applicant: Pan Medical , Ltd.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2016-09-01
Decision date: 2016-11-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Gloucester, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.