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FDA 510(k)

TruClear Elite Hysteroscope

K-Number: K180496 · 2018-08-29

ApplicantCovidien
Decision Date2018-08-29
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TruClear Elite Hysteroscope is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2018-08-29 under approval number K180496. 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 TruClear Elite Hysteroscope?

TruClear Elite Hysteroscope is a medical device that received FDA 510(k) clearance on 2018-08-29. It is manufactured by Covidien. The 510(k) number is K180496.

When was TruClear Elite Hysteroscope approved by the FDA?

TruClear Elite Hysteroscope received FDA 510(k) clearance on 2018-08-29, under approval number K180496.

What company makes TruClear Elite Hysteroscope?

TruClear Elite Hysteroscope is manufactured by Covidien.

What is the FDA product code for TruClear Elite Hysteroscope?

The FDA product code for TruClear Elite Hysteroscope is HIH.

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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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