SARNS MINI-SUCKER— 510(k) K810416

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K810416 for SARNS MINI-SUCKER, Substantially Equivalent on 1981-03-05. Applicant: 3M Health Care, Sarns. Device class: 1.

Clearance details

Applicant
3M Health Care, Sarns
Product code
Code GCY
Device class
Class 1
Regulation
21 CFR 878.4680
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GCY

product code GCY
Malfunction
786
Other
1
Total
787

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.