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FDA 510(k)

ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES

K-Number: K113062 · 2012-08-21

ApplicantEndoservice Optical Instruments GmbH
Decision Date2012-08-21
Product CodeFBP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Endoservice Optical Instruments GmbH. It received FDA 510(k) clearance on 2012-08-21 under 510(k) number K113062. The device is classified under product code FBP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES?

ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES is a medical device that received FDA 510(k) clearance on 2012-08-21. The listed applicant is Endoservice Optical Instruments GmbH. The 510(k) number is K113062.

When did ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES receive FDA 510(k) clearance?

ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES received FDA 510(k) clearance on 2012-08-21, under 510(k) number K113062.

Who is the listed applicant for ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES?

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

What is the FDA product code for ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES?

The FDA product code for ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES is FBP.

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Related Devices (Code: FBP)

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.

K031758ACMI M4 TELESCOPESAcmi CorporationK984607PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXXRichard Wolf Medical Instruments Corp.K760177TELESCOPE, RIGID ENDOSCOPEV. Mueller O.V. Baxter Healthcare Corp.

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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