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FDA 510(k)

Laparoscope Lens Shield Device (LENS)

K-Number: K170103 · 2017-02-16

ApplicantMedeon Biodesign, Inc.
Decision Date2017-02-16
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Laparoscope Lens Shield Device (LENS) is a medical device manufactured by Medeon Biodesign, Inc.. It received FDA 510(k) clearance on 2017-02-16 under approval number K170103. 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 2017-02-16. It is manufactured by Medeon Biodesign, Inc.. The 510(k) number is K170103.

When was Laparoscope Lens Shield Device (LENS) approved by the FDA?

Laparoscope Lens Shield Device (LENS) received FDA 510(k) clearance on 2017-02-16, under approval number K170103.

What company makes Laparoscope Lens Shield Device (LENS)?

Laparoscope Lens Shield Device (LENS) is manufactured by Medeon Biodesign, Inc..

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

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

Related Clinical Trials

NCT06604884 NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study RECRUITING

Other Devices by Medeon Biodesign, Inc.

K160117AbClose - Port Site Closure Device K160172Laparoscope Lens Shield Device K192891Laparoscope Lens Shield Device (LENS) K200902ClickClean K193652AbClose - Port Site Closure Device

Related Devices (Code: GCJ)

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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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