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FDA 510(k)

Aesculap Optilene Nonabsorbable Suture

K-Number: K180321 · 2018-03-07

Decision Date2018-03-07
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aesculap Optilene Nonabsorbable Suture is a medical device manufactured by Aesculap, Inc.. It received FDA 510(k) clearance on 2018-03-07 under approval number K180321. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aesculap Optilene Nonabsorbable Suture?

Aesculap Optilene Nonabsorbable Suture is a medical device that received FDA 510(k) clearance on 2018-03-07. It is manufactured by Aesculap, Inc.. The 510(k) number is K180321.

When was Aesculap Optilene Nonabsorbable Suture approved by the FDA?

Aesculap Optilene Nonabsorbable Suture received FDA 510(k) clearance on 2018-03-07, under approval number K180321.

What company makes Aesculap Optilene Nonabsorbable Suture?

Aesculap Optilene Nonabsorbable Suture is manufactured by Aesculap, Inc..

What is the FDA product code for Aesculap Optilene Nonabsorbable Suture?

The FDA product code for Aesculap Optilene Nonabsorbable Suture is GAW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.