SANICLAVE 102, MODEL RS-SC-102— 510(k) K122978

Substantially Equivalent

Alternative Pioneering Research and Development

FDA 510(k) clearance K122978 for SANICLAVE 102, MODEL RS-SC-102, Substantially Equivalent on 2013-05-23. Applicant: Alternative Pioneering Research and Development.

Clearance details

Applicant: Alternative Pioneering Research and Development
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2012-09-26
Decision date: 2013-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shafer, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.