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510(k) K192953

APTOS Threads – Polypropylene Surgical Sutures by Aptos, LLC — Product Code GAW

K192953 is an FDA 510(k) premarket notification submitted by Aptos, LLC for the device "APTOS Threads – Polypropylene Surgical Sutures". The FDA issued a decision of Substantially Equivalent on August 27, 2020. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2020
Date Received
October 21, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

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  • K193530 — Deklene MAXX (March 19, 2020)
  • K191299 — Silhouette Featherlift / Silhouette Lift (June 14, 2019)
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  • K180321 — Aesculap Optilene Nonabsorbable Suture (March 7, 2018)
  • K173644 — Gazelle Polypropylene Suture and Delivery Device (February 15, 2018)

FDA data resources