Cleared Traditional

SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE

K032468 · Suturtek Incorporated · General & Plastic Surgery

Sep 2003

Decision

43d

Days

Class 2

Risk

About This 510(k) Submission

K032468 is an FDA 510(k) clearance for the SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE, a Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Class II — Special Controls, product code GAQ), submitted by Suturtek Incorporated (Hopkonton, US). The FDA issued a Cleared decision on September 23, 2003, 43 days after receiving the submission on August 11, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4495.

Submission Details

510(k) Number	K032468 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2003
Decision Date	September 23, 2003
Days to Decision	43 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GAQ — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4495