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FDA 510(k)

RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES

K-Number: K082902 · 2008-12-10

ApplicantRz Medizintechnik GmbH
Decision Date2008-12-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Rz Medizintechnik GmbH. It received FDA 510(k) clearance on 2008-12-10 under 510(k) number K082902. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES?

RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2008-12-10. The listed applicant is Rz Medizintechnik GmbH. The 510(k) number is K082902.

When did RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES receive FDA 510(k) clearance?

RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES received FDA 510(k) clearance on 2008-12-10, under 510(k) number K082902.

Who is the listed applicant for RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES?

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

What is the FDA product code for RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES?

The FDA product code for RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES is GEI.

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 Rz Medizintechnik 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.

K243382RZ Resectoscope System

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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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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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