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FDA 510(k)

OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL

K-Number: K053583 · 2006-03-31

ApplicantOptivia Medical, LLC
Decision Date2006-03-31
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL is the device name listed in this FDA 510(k) record. The listed applicant is Optivia Medical, LLC. It received FDA 510(k) clearance on 2006-03-31 under 510(k) number K053583. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL?

OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL is a medical device that received FDA 510(k) clearance on 2006-03-31. The listed applicant is Optivia Medical, LLC. The 510(k) number is K053583.

When did OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL receive FDA 510(k) clearance?

OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL received FDA 510(k) clearance on 2006-03-31, under 510(k) number K053583.

Who is the listed applicant for OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL?

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

What is the FDA product code for OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL?

The FDA product code for OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL is HIH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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