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)

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 a medical device manufactured by Medeon Biodesign, Inc.. It received FDA 510(k) clearance on 2019-11-07 under approval 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. It is manufactured by Medeon Biodesign, Inc.. The 510(k) number is K192891.

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

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

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 K170103Laparoscope Lens Shield Device (LENS) K200902ClickClean K193652AbClose - Port Site Closure Device

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.

↑