BELLECUP— 510(k) K092985

Substantially Equivalent

Librette, Inc.

FDA 510(k) clearance K092985 for BELLECUP, Substantially Equivalent on 2010-06-28. Applicant: Librette, Inc..

Clearance details

Applicant: Librette, Inc.
Product code: Code HHE
Advisory panel: Obstetrics/Gynecology
Date received: 2009-09-28
Decision date: 2010-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HHE

product code HHE

Injury: 344
Total: 344

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.