KRONNER REINFORCING STYLETTE— 510(k) K932432

Substantially Equivalent

Unimar, Inc.

FDA 510(k) clearance K932432 for KRONNER REINFORCING STYLETTE, Substantially Equivalent on 1994-04-12. Applicant: Unimar, Inc..

Clearance details

Applicant: Unimar, Inc.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 1993-05-20
Decision date: 1994-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilton, CT, US

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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.