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FDA 510(k)

Aesculap Optilene Nonabsorbable Suture

K-Number: K180321 · 2018-03-07

ApplicantAesculap, Inc.
Decision Date2018-03-07
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aesculap Optilene Nonabsorbable Suture is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2018-03-07 under 510(k) 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. The listed applicant is Aesculap, Inc.. The 510(k) number is K180321.

When did Aesculap Optilene Nonabsorbable Suture receive FDA 510(k) clearance?

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

Who is the listed applicant for Aesculap Optilene Nonabsorbable Suture?

The FDA 510(k) record lists Aesculap, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Aesculap, Inc. as applicant

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Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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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