DeviceClearance

HEMOCLIP SURGICAL OCCLUDING CLIP— 510(k) K800079

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K800079 for HEMOCLIP SURGICAL OCCLUDING CLIP, Substantially Equivalent on 1980-01-28. Applicant: Edward Weck, Inc.. Device class: 2.

Clearance details

Applicant
Edward Weck, Inc.
Product code
Code FZP
Device class
Class 2
Regulation
21 CFR 878.4300
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 FZP

product code FZP
Death
11
Injury
726
Malfunction
10,830
Other
1
Total
11,568

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 →

Recalls naming K800079

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K800079.

Data sourced from openFDA. This site is unofficial and independent of the FDA.