Non absorbable Surgical Polyester Suture

FDA 510(k) K231183 · Shandong Haidike Medical Products Co., Ltd.

Substantially Equivalent

510(k) numberK231183

Submission

Device name
Non absorbable Surgical Polyester Suture
Applicant
Shandong Haidike Medical Products Co., Ltd.
Heze, CN
Received
April 26, 2023
Decision date
August 25, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 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

Other 510(k)s with product code GAT

510(k)DeviceApplicantDecision
K253910Stitch - Suture Wires and TapesGAT · Traditional GM Dos Reis Industria e Comercio Ltda.08/22/2026SE
K261021EasyWhip FamilyGAT · Traditional Winter Innovations, Inc.07/01/2026SE
K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™GAT · Traditional Teleflex Medical, LLC05/06/2026SE
K254275HyperSuture All Green Extension LineGAT · Traditional Threadstone, LLC03/23/2026SE
K254188Meniscus VersaflexGAT · Traditional GM Dos Reis Industria e Comercio Ltda.02/19/2026SE
K253145Pre-Sutured TendonGAT · Special Rti Surgical, Inc.10/22/2025SE
K253024ProZip Knotless ImplantGAT · Special Riverpoint Medical10/16/2025SE
K252225PowerKnot High Strength SuturesGAT · Traditional Medacta International S.A.09/12/2025SE
K252201HS FiberGAT · Special Riverpoint Medical08/13/2025SE
K242201HyperSuture White/Green Extension LineGAT · Traditional Threadstone, LLC03/27/2025SE

More from Threadstone, LLC

510(k)DeviceDecision
K230746Non absorbable Surgical Polypropylene SutureGAW · Traditional 09/14/2023SE
K210518Surgical Face MaskFXX · Traditional 06/14/2021SE

Questions and answers

When was Non absorbable Surgical Polyester Suture cleared by the FDA?

Non absorbable Surgical Polyester Suture (K231183) received a 510(k) decision of Substantially Equivalent on August 25, 2023, 121 days after the submission was received.

What is the product code of K231183?

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