DeviceClearance

SpeedStitch Suture Passer +2 more— 510(k) K163142

Substantially Equivalent

ArthroCare Corporation

FDA 510(k) clearance K163142 for SpeedStitch Suture Passer +2 more, Substantially Equivalent on 2017-01-06. Applicant: ArthroCare Corporation. Device class: 2.

Clearance details

Device name as filed
SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader
Applicant
ArthroCare Corporation
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
Special
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

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More clearances from ArthroCare Corporation

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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 K163142

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 K163142.

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