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FDA 510(k)

PTFE SURGICAL SUTURE

K-Number: K180630 · 2018-04-06

ApplicantOmnia Spa
Decision Date2018-04-06
Product CodeNBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PTFE SURGICAL SUTURE is a medical device manufactured by Omnia Spa. It received FDA 510(k) clearance on 2018-04-06 under approval number K180630. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTFE SURGICAL SUTURE?

PTFE SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 2018-04-06. It is manufactured by Omnia Spa. The 510(k) number is K180630.

When was PTFE SURGICAL SUTURE approved by the FDA?

PTFE SURGICAL SUTURE received FDA 510(k) clearance on 2018-04-06, under approval number K180630.

What company makes PTFE SURGICAL SUTURE?

PTFE SURGICAL SUTURE is manufactured by Omnia Spa.

What is the FDA product code for PTFE SURGICAL SUTURE?

The FDA product code for PTFE SURGICAL SUTURE is NBY.

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Related Devices (Code: NBY)

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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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