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FDA 510(k)

VARI-PASS VARIABLE LENGTH ACCESS SHEATH

K-Number: K123170 · 2013-02-04

ApplicantOlympus Surgical Technologies America
Decision Date2013-02-04
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VARI-PASS VARIABLE LENGTH ACCESS SHEATH 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 2013-02-04 under 510(k) number K123170. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARI-PASS VARIABLE LENGTH ACCESS SHEATH?

VARI-PASS VARIABLE LENGTH ACCESS SHEATH is a medical device that received FDA 510(k) clearance on 2013-02-04. The listed applicant is Olympus Surgical Technologies America. The 510(k) number is K123170.

When did VARI-PASS VARIABLE LENGTH ACCESS SHEATH receive FDA 510(k) clearance?

VARI-PASS VARIABLE LENGTH ACCESS SHEATH received FDA 510(k) clearance on 2013-02-04, under 510(k) number K123170.

Who is the listed applicant for VARI-PASS VARIABLE LENGTH ACCESS SHEATH?

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 VARI-PASS VARIABLE LENGTH ACCESS SHEATH?

The FDA product code for VARI-PASS VARIABLE LENGTH ACCESS SHEATH is KNY.

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Related Devices (Code: KNY)

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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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