DeviceClearance

GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL— 510(k) K053200

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K053200 for GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL, Substantially Equivalent on 2005-12-07. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant
W. L. Gore & Associates, Inc.
Product code
Code FTL
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Flagstaff, AZ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FTL

product code FTL
Death
317
Injury
66,072
Malfunction
1,273
Other
3
Total
67,665

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 K053200

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 K053200.

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