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FDA 510(k)

CONFIDENT SURGERY SUITE 300, MODEL CSS300

K-Number: K101887 · 2011-03-22

ApplicantSurgiceye GmbH
Decision Date2011-03-22
Product CodeIZD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CONFIDENT SURGERY SUITE 300, MODEL CSS300 is the device name listed in this FDA 510(k) record. The listed applicant is Surgiceye GmbH. It received FDA 510(k) clearance on 2011-03-22 under 510(k) number K101887. The device is classified under product code IZD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONFIDENT SURGERY SUITE 300, MODEL CSS300?

CONFIDENT SURGERY SUITE 300, MODEL CSS300 is a medical device that received FDA 510(k) clearance on 2011-03-22. The listed applicant is Surgiceye GmbH. The 510(k) number is K101887.

When did CONFIDENT SURGERY SUITE 300, MODEL CSS300 receive FDA 510(k) clearance?

CONFIDENT SURGERY SUITE 300, MODEL CSS300 received FDA 510(k) clearance on 2011-03-22, under 510(k) number K101887.

Who is the listed applicant for CONFIDENT SURGERY SUITE 300, MODEL CSS300?

The FDA 510(k) record lists Surgiceye GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONFIDENT SURGERY SUITE 300, MODEL CSS300?

The FDA product code for CONFIDENT SURGERY SUITE 300, MODEL CSS300 is IZD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Surgiceye GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123917DECLIPSESPECT VIEWER

Related Devices (Code: IZD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123917DECLIPSESPECT VIEWERSurgiceye GmbHK013751HANDHELD GAMMA FINDER (HGF)Silicon Instruments GmhbK983768MODIFICATION TO GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.K982442C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)Care Wise Medical Products Corp.K971167NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESNeoprobe Corp.K961321GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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