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FDA 510(k)

Laparoscope Lens Shield Device (LENS)

K-Number: K192891 · 2019-11-07

ApplicantMedeon Biodesign, Inc.
Decision Date2019-11-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Laparoscope Lens Shield Device (LENS) is the device name listed in this FDA 510(k) record. The listed applicant is Medeon Biodesign, Inc.. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K192891. 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 Laparoscope Lens Shield Device (LENS)?

Laparoscope Lens Shield Device (LENS) is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Medeon Biodesign, Inc.. The 510(k) number is K192891.

When did Laparoscope Lens Shield Device (LENS) receive FDA 510(k) clearance?

Laparoscope Lens Shield Device (LENS) received FDA 510(k) clearance on 2019-11-07, under 510(k) number K192891.

Who is the listed applicant for Laparoscope Lens Shield Device (LENS)?

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

What is the FDA product code for Laparoscope Lens Shield Device (LENS)?

The FDA product code for Laparoscope Lens Shield Device (LENS) is GCJ.

Other records listing Medeon Biodesign, 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.

K200902ClickCleanK193652AbClose - Port Site Closure DeviceK170103Laparoscope Lens Shield Device (LENS)K160117AbClose - Port Site Closure DeviceK160172Laparoscope Lens Shield Device

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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