Cleared Traditional

GRAFT DELIVERY SYSTEM MODEL SA-6115

K100754 · Micromedics, Inc. · General Hospital
Jun 2010
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K100754 is an FDA 510(k) clearance for the GRAFT DELIVERY SYSTEM MODEL SA-6115, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Micromedics, Inc. (St Paul, US). The FDA issued a Cleared decision on June 9, 2010, 84 days after receiving the submission on March 17, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K100754 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2010
Decision Date June 09, 2010
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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