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FDA 510(k)

CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control

K-Number: K182882 · 2018-11-14

ApplicantConmed Corporation
Decision Date2018-11-14
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2018-11-14 under approval number K182882. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control?

CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control is a medical device that received FDA 510(k) clearance on 2018-11-14. It is manufactured by Conmed Corporation. The 510(k) number is K182882.

When was CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control approved by the FDA?

CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control received FDA 510(k) clearance on 2018-11-14, under approval number K182882.

What company makes CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control?

CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control is manufactured by Conmed Corporation.

What is the FDA product code for CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control?

The FDA product code for CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control is HRX.

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Related PubMed Literature

PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

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Related Devices (Code: HRX)

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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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