PD Synth, Absorbable (Poly Dioxanone) Suture

Q: What is the product code of K081001?

The FDA product code is NEW – Suture, Surgical, Absorbable, Polydioxanone, a Class II (moderate risk) device regulated under 21 CFR 878.4840.

FDA 510(k) K081001 · Sutures India Pvt., Ltd.

Substantially Equivalent

510(k) numberK081001

Submission

Device name: PD Synth, Absorbable (Poly Dioxanone) Suture
Applicant: Sutures India Pvt., Ltd.
Bangalore, IN
Received: April 8, 2008
Decision date: June 9, 2008
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NEW – Suture, Surgical, Absorbable, Polydioxanone
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4840
Specialty: General, Plastic Surgery
Implant: Yes

Other 510(k)s with product code NEW

510(k)	Device	Applicant	Decision
K253879	Monofix PdoNEW · Traditional	Samyang Holdings Corporation	08/25/2026SE
K261988	Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureNEW · Special	Teleflex Medical, LLC	07/09/2026SE
K252171	Barbed PDO SutureNEW · Traditional	Sutura Medical Technology, Inc.	06/12/2026SE
K252047	STRATAFIX Symmetric PDS Plus Knotless Tissue Control DevicesNEW · Traditional	ETHICON, Inc.	05/18/2026SE
K243897	PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureNEW · Traditional	ETHICON, Inc.	11/12/2025SE
K251414	Miracu Polydioxanone (PDO) Suture and Needle (MONO)NEW · Traditional	Feeltech Co., Ltd.	10/20/2025SE
K250107	V-soft Line Barbed Surgical Suture (Various)NEW · Traditional	Feeltech Co., Ltd.	10/15/2025SE
K252644	PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION…NEW · Special	M/s. Meril Endo Surgery Private Limited.	09/23/2025SE
K250977	Suture-TOOL SystemNEW · Special	Suturion AB	04/28/2025SE
K242835	Suture-TOOL SystemNEW · Traditional	Suturion AB	01/22/2025SE

More from Suturion AB

510(k)	Device	Decision
K081003	Trusynth, Absorbable (Polyglactin 910) SutureGAM · Traditional	06/09/2008SE
K081002	Monoglyde, Absorbable (Poliglecaprone 25) SutureGAM · Traditional	06/09/2008SE
K060018	Trulene MeshFTL · Traditional	07/26/2006SE

Questions and answers

When was PD Synth, Absorbable (Poly Dioxanone) Suture cleared by the FDA?

PD Synth, Absorbable (Poly Dioxanone) Suture (K081001) received a 510(k) decision of Substantially Equivalent on June 9, 2008, 62 days after the submission was received.

What is the product code of K081001?

The FDA product code is NEW – Suture, Surgical, Absorbable, Polydioxanone, a Class II (moderate risk) device regulated under 21 CFR 878.4840.