Rejoni Intrauterine Catheter— 510(k) K222798

Substantially Equivalent

Rejoni, Inc.

FDA 510(k) clearance K222798 for Rejoni Intrauterine Catheter, Substantially Equivalent on 2022-12-16. Applicant: Rejoni, Inc..

Clearance details

Applicant: Rejoni, Inc.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2022-09-16
Decision date: 2022-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

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.