RESIN 11— 510(k) K121170

Substantially Equivalent

Respinnovation Sas

FDA 510(k) clearance K121170 for RESIN 11, Substantially Equivalent on 2012-07-13. Applicant: Respinnovation Sas.

Clearance details

Applicant: Respinnovation Sas
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 2012-04-17
Decision date: 2012-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.