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FDA 510(k)

MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE

K-Number: K013274 · 2001-11-16

ApplicantCp Medical
Decision Date2001-11-16
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Cp Medical. It received FDA 510(k) clearance on 2001-11-16 under 510(k) number K013274. 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 MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE?

MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE is a medical device that received FDA 510(k) clearance on 2001-11-16. The listed applicant is Cp Medical. The 510(k) number is K013274.

When did MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE receive FDA 510(k) clearance?

MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE received FDA 510(k) clearance on 2001-11-16, under 510(k) number K013274.

Who is the listed applicant for MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE?

The FDA 510(k) record lists Cp Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE?

The FDA product code for MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE 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 Cp Medical 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.

K094028CP-FIBER (ORTHOFIBER)K072229MONOSWIFTK071550PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERSK060987OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31K041894ORTHOFIBERK034062CP SLEEVE AND RIVER SLEEVE

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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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