Cleared Traditional

GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,

K101180 · Smiths Medical MD, Inc. · General Hospital
Aug 2010
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K101180 is an FDA 510(k) clearance for the GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Smiths Medical MD, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 3, 2010, 98 days after receiving the submission on April 27, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K101180 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2010
Decision Date August 03, 2010
Days to Decision 98 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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