Cleared Special

Deklene MAXX

K193530 · Teleflex Medical · General & Plastic Surgery
Mar 2020
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K193530 is an FDA 510(k) clearance for the Deklene MAXX, a Suture, Nonabsorbable, Synthetic, Polypropylene (Class II — Special Controls, product code GAW), submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on March 19, 2020, 90 days after receiving the submission on December 20, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5010.

Submission Details

510(k) Number K193530 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2019
Decision Date March 19, 2020
Days to Decision 90 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GAW — Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5010

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