Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE

K-Number: K053380 · 2006-01-18

ApplicantSurgical Specialties Corp
Decision Date2006-01-18
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Specialties Corp. It received FDA 510(k) clearance on 2006-01-18 under 510(k) number K053380. 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 CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE?

CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE is a medical device that received FDA 510(k) clearance on 2006-01-18. The listed applicant is Surgical Specialties Corp. The 510(k) number is K053380.

When did CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE receive FDA 510(k) clearance?

CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE received FDA 510(k) clearance on 2006-01-18, under 510(k) number K053380.

Who is the listed applicant for CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE?

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

What is the FDA product code for CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE?

The FDA product code for CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED 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 Surgical Specialties Corp 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.

K080985QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)K080680QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONEK071989QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIALK072028QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERMK063680SHARPOINT PDO (POLYDIOXANONE) SUTURESK052962OPTIMIZED BARB DESIGN

View all 19 devices →

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.

↑