Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17

Q: What is the product code of K063603?

The FDA product code is GAQ – Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, a Class II (moderate risk) device regulated under 21 CFR 878.4495.

FDA 510(k) K063603 · Suturtek Incorporated

Substantially Equivalent

510(k) numberK063603

Submission

Device name: Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
Applicant: Suturtek Incorporated
Acton, MA, US
Received: December 3, 2006
Decision date: February 7, 2007
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GAQ – Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4495
Specialty: General, Plastic Surgery
Implant: Yes

Other 510(k)s with product code GAQ

510(k)	Device	Applicant	Decision
K203855	CoNextions TR Tendon Repair SystemGAQ · Traditional	Conextions Medical	04/22/2022SE
K193209	Wego-Stainless SteelGAQ · Traditional	Foosin Medical Supplies Inc., Ltd.	02/19/2020SE
K172146	MeristeelGAQ · Traditional	M/s. Meril Endo Surgery Private Limited.	02/01/2018SE
K170767	Surgical Stainless Steel Suture, Stainless Steel SutureGAQ · Special	ETHICON, Inc.	11/01/2017SE
K141007	Demesteel (Stainless Steel) Non-Absorbable SutureGAQ · Traditional	Demetech Corp.	09/25/2014SE
K140127	Ferrofibre Stainless Steel Suture with CrimpGAQ · Special	Pontis Orthopaedics, LLC	05/28/2014SE
K081060	Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5GAQ · Abbreviated	Core Essence Orthopaedics, LLC	12/24/2008SE
K082828	Suturtek 360 Degree Sternal Closure DeviceGAQ · Special	Suturtek Incorporated	10/14/2008SE
K042606	Modification To:Synthes (USA) Titanium WireGAQ · Traditional	Synthes (Usa)	05/27/2005SE
K041333	Synthes (USA) Titanium WireGAQ · Traditional	Synthes (Usa)	08/27/2004SE

More from Synthes (Usa)

510(k)	Device	Decision
K082828	Suturtek 360 Degree Sternal Closure DeviceGAQ · Special	10/14/2008SE
K032468	Suturtek Fastclose Sternum Closure DeviceGAQ · Traditional	09/23/2003SE
K030227	Suturtek Fastclose Suturing DeviceGAL · Traditional	03/17/2003SE

Questions and answers

When was Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 cleared by the FDA?

Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 (K063603) received a 510(k) decision of Substantially Equivalent on February 7, 2007, 66 days after the submission was received.

What is the product code of K063603?

The FDA product code is GAQ – Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, a Class II (moderate risk) device regulated under 21 CFR 878.4495.