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)

SIMPLYSTRONG, SIMPLYEZEE

K-Number: K181791 · 2018-08-21

ApplicantGenicon, Inc.
Decision Date2018-08-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SIMPLYSTRONG, SIMPLYEZEE is the device name listed in this FDA 510(k) record. The listed applicant is Genicon, Inc.. It received FDA 510(k) clearance on 2018-08-21 under 510(k) number K181791. 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 SIMPLYSTRONG, SIMPLYEZEE?

SIMPLYSTRONG, SIMPLYEZEE is a medical device that received FDA 510(k) clearance on 2018-08-21. The listed applicant is Genicon, Inc.. The 510(k) number is K181791.

When did SIMPLYSTRONG, SIMPLYEZEE receive FDA 510(k) clearance?

SIMPLYSTRONG, SIMPLYEZEE received FDA 510(k) clearance on 2018-08-21, under 510(k) number K181791.

Who is the listed applicant for SIMPLYSTRONG, SIMPLYEZEE?

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

What is the FDA product code for SIMPLYSTRONG, SIMPLYEZEE?

The FDA product code for SIMPLYSTRONG, SIMPLYEZEE is GCJ.

Other records listing Genicon, Inc. 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.

K190168Aquas ProbesK180836GenistrongK180579Ezee RetrievalK171752X-SURGEK162059EZEE RETRIEVAL

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.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

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.

↑