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)

COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE

K-Number: K021019 · 2002-06-18

ApplicantGenzyme Corp.
Decision Date2002-06-18
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 2002-06-18 under 510(k) number K021019. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE?

COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE is a medical device that received FDA 510(k) clearance on 2002-06-18. The listed applicant is Genzyme Corp.. The 510(k) number is K021019.

When did COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE receive FDA 510(k) clearance?

COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE received FDA 510(k) clearance on 2002-06-18, under 510(k) number K021019.

Who is the listed applicant for COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE?

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

What is the FDA product code for COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE?

The FDA product code for COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE is GAT.

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 Genzyme 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.

K061508OSOM INFLUENZA A&B TESTK051244GENZYME OSOM INFLUENZA A & B TESTK040241N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SETK040868SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESHK033864GENZYME OSOM TRICHOMONAS RAPID TESTK023544GENZYME CONTRAST II HCG URINE/SERUM TEST

View all 27 devices →

Related Devices (Code: GAT)

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, 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.

↑