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

FDA 510(k)

CORE E3 Suction/irrigator

K-Number: K202303 · 2021-02-19

Decision Date2021-02-19
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORE E3 Suction/irrigator is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K202303. 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 CORE E3 Suction/irrigator?

CORE E3 Suction/irrigator is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Conmed Corporation. The 510(k) number is K202303.

When did CORE E3 Suction/irrigator receive FDA 510(k) clearance?

CORE E3 Suction/irrigator received FDA 510(k) clearance on 2021-02-19, under 510(k) number K202303.

Who is the listed applicant for CORE E3 Suction/irrigator?

The FDA 510(k) record lists Conmed Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORE E3 Suction/irrigator?

The FDA product code for CORE E3 Suction/irrigator is GCJ.

Other records listing Conmed Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 48 devices →

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.