DeviceClearance

PROLENE POLYPROPYLENE NONABSORBABLE SUTURE— 510(k) K133356

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K133356 for PROLENE POLYPROPYLENE NONABSORBABLE SUTURE, Substantially Equivalent on 2013-12-06. Applicant: ETHICON, Inc.. Device class: 2.

Clearance details

Applicant
ETHICON, Inc.
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
Somerville, NJ, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code GAW

view all

More clearances from ETHICON, Inc.

view all

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 K133356

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 K133356.

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