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FDA 510(k)

CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners

K-Number: K160900 · 2016-05-31

ApplicantC.R. Bard, Inc.
Decision Date2016-05-31
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-05-31 under approval number K160900. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners?

CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners is a medical device that received FDA 510(k) clearance on 2016-05-31. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K160900.

When was CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners approved by the FDA?

CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners received FDA 510(k) clearance on 2016-05-31, under approval number K160900.

What company makes CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners?

CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners is manufactured by C.R. Bard, Inc..

What is the FDA product code for CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners?

The FDA product code for CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners is GDW.

Related Clinical Trials

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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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