Cleared Traditional

DUAL SYRINGE HOLDER

K082110 · Surgin Surgical Instrumentation, Inc. · General Hospital
Jun 2009
Decision
324d
Days
Class 2
Risk

About This 510(k) Submission

K082110 is an FDA 510(k) clearance for the DUAL SYRINGE HOLDER, a Stopcock, I.v. Set (Class II — Special Controls, product code FMG), submitted by Surgin Surgical Instrumentation, Inc. (Irvine, US). The FDA issued a Cleared decision on June 17, 2009, 324 days after receiving the submission on July 28, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K082110 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2008
Decision Date June 17, 2009
Days to Decision 324 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FMG — Stopcock, I.v. Set
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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