Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters— 510(k) K152557

Name: FDA 510(k) clearance K152557
Creator: U.S. Food and Drug Administration
Published: 2016-02-23

Substantially Equivalent

G21, S.R.L.

FDA 510(k) clearance K152557 for Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters, Substantially Equivalent on 2016-02-23. Applicant: G21, S.R.L.. Device class: 2.

Clearance details

Applicant: G21, S.R.L.
Product code: Code NDN
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2015-09-08
Decision date: 2016-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Possidonio, IT

Download summary PDF View on FDA.gov ↗

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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.