Confident Surgery Suite 300, Model CSS300

FDA 510(k) K101887 · Surgiceye GmbH

Substantially Equivalent

510(k) numberK101887

Submission

Device name
Confident Surgery Suite 300, Model CSS300
Applicant
Surgiceye GmbH
Munich, Bavaria, DE
Received
July 6, 2010
Decision date
March 22, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IZD – Probe, Uptake, Nuclear
Device class
Class I (low risk)
Regulation
21 CFR 892.1320
Specialty
Radiology

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More from Biodan Medical Systems, Ltd.

510(k)DeviceDecision
K133781Declipsespect LaparoscopyIZD · Traditional 04/11/2014SE
K123917Declipsespect ViewerIZD · Special 01/25/2013SE

Questions and answers

When was Confident Surgery Suite 300, Model CSS300 cleared by the FDA?

Confident Surgery Suite 300, Model CSS300 (K101887) received a 510(k) decision of Substantially Equivalent on March 22, 2011, 259 days after the submission was received.

What is the product code of K101887?

The FDA product code is IZD – Probe, Uptake, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1320.