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FDA 510(k)

UNIVERSAL IRRIGATION SOLUTION HYBRID

K-Number: K102855 · 2010-11-19

ApplicantByrne Medical, Inc.
Decision Date2010-11-19
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL IRRIGATION SOLUTION HYBRID is the device name listed in this FDA 510(k) record. The listed applicant is Byrne Medical, Inc.. It received FDA 510(k) clearance on 2010-11-19 under 510(k) number K102855. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL IRRIGATION SOLUTION HYBRID?

UNIVERSAL IRRIGATION SOLUTION HYBRID is a medical device that received FDA 510(k) clearance on 2010-11-19. The listed applicant is Byrne Medical, Inc.. The 510(k) number is K102855.

When did UNIVERSAL IRRIGATION SOLUTION HYBRID receive FDA 510(k) clearance?

UNIVERSAL IRRIGATION SOLUTION HYBRID received FDA 510(k) clearance on 2010-11-19, under 510(k) number K102855.

Who is the listed applicant for UNIVERSAL IRRIGATION SOLUTION HYBRID?

The FDA 510(k) record lists Byrne Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIVERSAL IRRIGATION SOLUTION HYBRID?

The FDA product code for UNIVERSAL IRRIGATION SOLUTION HYBRID is OCX.

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Other records listing Byrne Medical, Inc. as applicant

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Related Devices (Code: OCX)

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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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