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FDA 510(k)

PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE

K-Number: K081001 · 2008-06-09

ApplicantSutures India Pvt., Ltd.
Decision Date2008-06-09
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Sutures India Pvt., Ltd.. It received FDA 510(k) clearance on 2008-06-09 under 510(k) number K081001. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE?

PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE is a medical device that received FDA 510(k) clearance on 2008-06-09. The listed applicant is Sutures India Pvt., Ltd.. The 510(k) number is K081001.

When did PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE receive FDA 510(k) clearance?

PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE received FDA 510(k) clearance on 2008-06-09, under 510(k) number K081001.

Who is the listed applicant for PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE?

The FDA 510(k) record lists Sutures India Pvt., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE?

The FDA product code for PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE is NEW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sutures India Pvt., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081002MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTUREK081003TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTUREK060018TRULENE MESH

Related Devices (Code: NEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254238MINT MONO SuturesHans Biomed CorporationK253879MONOFIX PDOSamyang Holdings CorporationK261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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