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FDA 510(k)

PROcedure Rehearsal Studio

K-Number: K153705 · 2016-09-02

Applicant3Dsystems, Simbionix Products
Decision Date2016-09-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROcedure Rehearsal Studio is the device name listed in this FDA 510(k) record. The listed applicant is 3Dsystems, Simbionix Products. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K153705. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROcedure Rehearsal Studio?

PROcedure Rehearsal Studio is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is 3Dsystems, Simbionix Products. The 510(k) number is K153705.

When did PROcedure Rehearsal Studio receive FDA 510(k) clearance?

PROcedure Rehearsal Studio received FDA 510(k) clearance on 2016-09-02, under 510(k) number K153705.

Who is the listed applicant for PROcedure Rehearsal Studio?

The FDA 510(k) record lists 3Dsystems, Simbionix Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROcedure Rehearsal Studio?

The FDA product code for PROcedure Rehearsal Studio is LLZ.

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

Official Source

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

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