DeviceClearance

MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE— 510(k) K050947

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K050947 for MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE, Substantially Equivalent on 2005-06-01. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 2.

Clearance details

Applicant
United States Surgical, A Division of Tyco Healthc
Product code
Code GAW
Device class
Class 2
Regulation
21 CFR 878.5010
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Norwalk, CT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GAW

product code GAW
Death
66
Injury
1,616
Malfunction
10,428
Total
12,110

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 K050947

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 K050947.

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