SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503— 510(k) K022043

Substantially Equivalent

Medennium, Inc.

FDA 510(k) clearance K022043 for SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503, Substantially Equivalent on 2002-10-18. Applicant: Medennium, Inc..

Clearance details

Applicant: Medennium, Inc.
Product code: Code LZU
Advisory panel: Unknown
Date received: 2002-06-24
Decision date: 2002-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code LZU

product code LZU

Other: 2
Total: 2

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.