Cleared Traditional

FAST THROW STAINLESS STEEL SURGICAL SUTURE

K030926 · Advanced Surgical Products, Inc. · General & Plastic Surgery
Jul 2003
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K030926 is an FDA 510(k) clearance for the FAST THROW STAINLESS STEEL SURGICAL SUTURE, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Advanced Surgical Products, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 21, 2003, 119 days after receiving the submission on March 24, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K030926 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2003
Decision Date July 21, 2003
Days to Decision 119 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FZP — Clip, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300

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