DeviceClearance

NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES— 510(k) K990952

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K990952 for NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES, Substantially Equivalent on 1999-04-01. 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 GAT
Device class
Class 2
Regulation
21 CFR 878.5000
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Norwalk, CT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GAT

product code GAT
Death
19
Injury
4,163
Malfunction
8,646
Other
2
Total
12,830

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 K990952

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 K990952.

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