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FDA 510(k)

Instrument basket, for EndoEYE

K-Number: K171692 · 2018-04-02

ApplicantOlympus Winter & Ibe GmbH
Decision Date2018-04-02
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Instrument basket, for EndoEYE is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2018-04-02 under 510(k) number K171692. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Instrument basket, for EndoEYE?

Instrument basket, for EndoEYE is a medical device that received FDA 510(k) clearance on 2018-04-02. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K171692.

When did Instrument basket, for EndoEYE receive FDA 510(k) clearance?

Instrument basket, for EndoEYE received FDA 510(k) clearance on 2018-04-02, under 510(k) number K171692.

Who is the listed applicant for Instrument basket, for EndoEYE?

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

What is the FDA product code for Instrument basket, for EndoEYE?

The FDA product code for Instrument basket, for EndoEYE is KCT.

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Related Devices (Code: KCT)

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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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