Renova Spine Balloon Catheter— 510(k) K231340

Substantially Equivalent

Biopsybell S.R.L.

FDA 510(k) clearance K231340 for Renova Spine Balloon Catheter, Substantially Equivalent on 2023-10-30. Applicant: Biopsybell S.R.L..

Clearance details

Applicant: Biopsybell S.R.L.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2023-05-09
Decision date: 2023-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mirandola, IT

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.