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FDA 510(k)

INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS

K-Number: K090584 · 2009-11-24

ApplicantCarl Zeiss Surgical GmbH
Decision Date2009-11-24
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Surgical GmbH. It received FDA 510(k) clearance on 2009-11-24 under 510(k) number K090584. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS?

INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS is a medical device that received FDA 510(k) clearance on 2009-11-24. The listed applicant is Carl Zeiss Surgical GmbH. The 510(k) number is K090584.

When did INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS receive FDA 510(k) clearance?

INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS received FDA 510(k) clearance on 2009-11-24, under 510(k) number K090584.

Who is the listed applicant for INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS?

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

What is the FDA product code for INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS?

The FDA product code for INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS is JAD.

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 Carl Zeiss Surgical 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.

K110590INTRABEAM NEEDLE APPLICATORK100468ZEISS INFRARED 800 WITH FLOW 800 OPTIONK051055INTRABEAM SYSTEM

Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, 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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