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FDA 510(k)

CleverLock Guidewire Locking Device and Biopsy Cap

K-Number: K190164 · 2019-04-04

ApplicantOlympus Surgical Technologies America
Decision Date2019-04-04
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CleverLock Guidewire Locking Device and Biopsy Cap is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Surgical Technologies America. It received FDA 510(k) clearance on 2019-04-04 under 510(k) number K190164. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CleverLock Guidewire Locking Device and Biopsy Cap?

CleverLock Guidewire Locking Device and Biopsy Cap is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Olympus Surgical Technologies America. The 510(k) number is K190164.

When did CleverLock Guidewire Locking Device and Biopsy Cap receive FDA 510(k) clearance?

CleverLock Guidewire Locking Device and Biopsy Cap received FDA 510(k) clearance on 2019-04-04, under 510(k) number K190164.

Who is the listed applicant for CleverLock Guidewire Locking Device and Biopsy Cap?

The FDA 510(k) record lists Olympus Surgical Technologies America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CleverLock Guidewire Locking Device and Biopsy Cap?

The FDA product code for CleverLock Guidewire Locking Device and Biopsy Cap is ODC.

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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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