Cleared Traditional

SafePath Suturing System

K180701 · Safepath Medical, Inc. · General & Plastic Surgery
Jun 2018
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K180701 is an FDA 510(k) clearance for the SafePath Suturing System, a Suture, Nonabsorbable, Silk (Class II — Special Controls, product code GAP), submitted by Safepath Medical, Inc. (Amesbury, US). The FDA issued a Cleared decision on June 25, 2018, 101 days after receiving the submission on March 16, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5030.

Submission Details

510(k) Number K180701 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2018
Decision Date June 25, 2018
Days to Decision 101 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GAP — Suture, Nonabsorbable, Silk
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5030

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