Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EnlightenVue Microendoscopy System

K-Number: K192300 · 2020-03-20

ApplicantEnlightenvue, Inc.
Decision Date2020-03-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EnlightenVue Microendoscopy System is a medical device manufactured by Enlightenvue, Inc.. It received FDA 510(k) clearance on 2020-03-20 under approval number K192300. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EnlightenVue Microendoscopy System?

EnlightenVue Microendoscopy System is a medical device that received FDA 510(k) clearance on 2020-03-20. It is manufactured by Enlightenvue, Inc.. The 510(k) number is K192300.

When was EnlightenVue Microendoscopy System approved by the FDA?

EnlightenVue Microendoscopy System received FDA 510(k) clearance on 2020-03-20, under approval number K192300.

What company makes EnlightenVue Microendoscopy System?

EnlightenVue Microendoscopy System is manufactured by Enlightenvue, Inc..

What is the FDA product code for EnlightenVue Microendoscopy System?

The FDA product code for EnlightenVue Microendoscopy System is GCJ.

Related Devices (Code: GCJ)

K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien K160801Well Lead Extraction BagWell Lead Medical Co., Ltd. K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp. K161720Standard ClampStandard Bariatrics K162445LiVac Retractor SystemLivac Pty, Ltd. K162584VersaOne Bladeless TrocarCovidien

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.

↑