Cleared Abbreviated

AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH

K102460 · Summit Medical Products, Inc. · Anesthesiology
Jan 2011
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K102460 is an FDA 510(k) clearance for the AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH, a Catheter, Conduction, Anesthetic (Class II — Special Controls, product code BSO), submitted by Summit Medical Products, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 13, 2011, 139 days after receiving the submission on August 27, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5120.

Submission Details

510(k) Number K102460 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2010
Decision Date January 13, 2011
Days to Decision 139 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSO — Catheter, Conduction, Anesthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5120

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