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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 a medical device manufactured by Teleflex Medical Incorporated. It received FDA 510(k) clearance on 2018-10-10 under approval 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. It is manufactured by Teleflex Medical Incorporated. The 510(k) number is K181774.

When was 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 approved by the FDA?

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 approval number K181774.

What company makes 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 manufactured by Teleflex Medical Incorporated.

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.

Related Clinical Trials

NCT03258580 Sociocultural & Biobehavioral Influences on Pain Expression and Assessment RECRUITING NCT07574086 Stratafix vs. PDS (Fascial Closure RCT) NOT_YET_RECRUITING NCT07569237 Patient-Reported Outcomes of Four Intraoral Suture Materials NOT_YET_RECRUITING NCT06272201 Incisionless Suture Plications in a POSE2.0 Obesity Study NOT_YET_RECRUITING NCT07498361 Comparative Analysis of fast-and Slow-absorbable Poly(Lactose-co-glycolide) Sutures in Oral Surgery: a Randomized Controlled Trial. RECRUITING NCT06636136 Transtibial Osseointegration RECRUITING

Other Devices by Teleflex Medical Incorporated

K172016Force Fiber Fusion Suture K191268Force Fiber Suture

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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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