MEDICON MOGEN CLAMP— 510(k) K100916

Substantially Equivalent

Medicon EG

FDA 510(k) clearance K100916 for MEDICON MOGEN CLAMP, Substantially Equivalent on 2010-12-06. Applicant: Medicon EG. Device class: 2.

Clearance details

Applicant
Medicon EG
Product code
Code HFX
Device class
Class 2
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tuttlingen, DE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HFX

product code HFX
Other
3
Total
3

Source: openFDA MAUDE database, through . 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.