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FDA 510(k)

APTOS Threads – Polypropylene Surgical Sutures

K-Number: K192953 · 2020-08-27

ApplicantAptos, LLC
Decision Date2020-08-27
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

APTOS Threads – Polypropylene Surgical Sutures is a medical device manufactured by Aptos, LLC. It received FDA 510(k) clearance on 2020-08-27 under approval number K192953. 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 APTOS Threads – Polypropylene Surgical Sutures?

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

When was APTOS Threads – Polypropylene Surgical Sutures approved by the FDA?

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

What company makes APTOS Threads – Polypropylene Surgical Sutures?

APTOS Threads – Polypropylene Surgical Sutures is manufactured by Aptos, LLC.

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

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

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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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