Ambit Tunneler

FDA 510(k) K110814 · Summit Medical Products, Inc.

Substantially Equivalent

510(k) numberK110814

Submission

Device name
Ambit Tunneler
Applicant
Summit Medical Products, Inc.
Salt Lake City, UT, US
Received
March 24, 2011
Decision date
April 8, 2011
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
BSO – Catheter, Conduction, Anesthetic
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5120
Specialty
Anesthesiology

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More from B.Braun Medical, Inc.

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K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent…MEA · Traditional 08/29/2017SE
K113043Direct Antibiotic Infusion KitLJS · Traditional 12/20/2011SE
K102460Ambit Introducer, Ambit Needle, Ambit SheathBSO · Abbreviated 01/13/2011SE

Questions and answers

When was Ambit Tunneler cleared by the FDA?

Ambit Tunneler (K110814) received a 510(k) decision of Substantially Equivalent on April 8, 2011, 15 days after the submission was received.

What is the product code of K110814?

The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.