SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader

Q: What is the product code of K163142?

The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.

FDA 510(k) K163142 · ArthroCare Corporation

Substantially Equivalent

510(k) numberK163142

Submission

Device name: SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader
Applicant: ArthroCare Corporation
Irvine, CA, US
Received: November 9, 2016
Decision date: January 6, 2017
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.5000
Specialty: General, Plastic Surgery
Implant: Yes

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K252225	PowerKnot High Strength SuturesGAT · Traditional	Medacta International S.A.	09/12/2025SE
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Questions and answers

When was SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader cleared by the FDA?

SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader (K163142) received a 510(k) decision of Substantially Equivalent on January 6, 2017, 58 days after the submission was received.

What is the product code of K163142?

The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.