FDA 510(k)

Fil APTOS - Sutures Chirurgicales en Polypropylène

Numéro K : K192953 · 2020-08-27

Date de décision2020-08-27

Code produitGAW

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

APTOS Threads – Polypropylene Surgical Sutures is the device name listed in this FDA 510(k) record. The listed applicant is Aptos, LLC. It received FDA 510(k) clearance on 2020-08-27 under 510(k) number K192953. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the APTOS Threads – Polypropylene Surgical Sutures?

APTOS Threads – Polypropylene Surgical Sutures is a medical device that received FDA 510(k) clearance on 2020-08-27. The listed applicant is Aptos, LLC. The 510(k) number is K192953.

When did APTOS Threads – Polypropylene Surgical Sutures receive FDA 510(k) clearance?

APTOS Threads – Polypropylene Surgical Sutures received FDA 510(k) clearance on 2020-08-27, under 510(k) number K192953.

Who is the listed applicant for APTOS Threads – Polypropylene Surgical Sutures?

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

What is the FDA product code for APTOS Threads – Polypropylene Surgical Sutures?

The FDA product code for APTOS Threads – Polypropylene Surgical Sutures is GAW.

Essais cliniques associés

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Dispositifs connexes (Code : GAW)

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris Medical K230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsi K193530Deklene MAXXTeleflex Medical

Source officielle

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