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FDA 510(k)

Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture

K-Number: K181774 · 2018-10-10

ApplicantTeleflex Medical Incorporated
Decision Date2018-10-10
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical Incorporated. It received FDA 510(k) clearance on 2018-10-10 under 510(k) number K181774. 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 Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture?

Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture is a medical device that received FDA 510(k) clearance on 2018-10-10. The listed applicant is Teleflex Medical Incorporated. The 510(k) number is K181774.

When did Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture receive FDA 510(k) clearance?

Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture received FDA 510(k) clearance on 2018-10-10, under 510(k) number K181774.

Who is the listed applicant for Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture?

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

What is the FDA product code for Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture?

The FDA product code for Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture is GAT.

Other records listing Teleflex Medical Incorporated 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.

K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureK260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™PMA P180025Device, hemostasis, vascularK251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsK242495LMA Fastrach ETT SUK243553QuikClot Control+ Hemostatic Device

View all 26 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.

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.K253024ProZip Knotless ImplantRiverpoint Medical

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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