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FDA 510(k)

LumenR Tissue Retractor System

K-Number: K153698 · 2016-04-19

ApplicantLumenr, LLC
Decision Date2016-04-19
Product CodeODB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LumenR Tissue Retractor System is the device name listed in this FDA 510(k) record. The listed applicant is Lumenr, LLC. It received FDA 510(k) clearance on 2016-04-19 under 510(k) number K153698. The device is classified under product code ODB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LumenR Tissue Retractor System?

LumenR Tissue Retractor System is a medical device that received FDA 510(k) clearance on 2016-04-19. The listed applicant is Lumenr, LLC. The 510(k) number is K153698.

When did LumenR Tissue Retractor System receive FDA 510(k) clearance?

LumenR Tissue Retractor System received FDA 510(k) clearance on 2016-04-19, under 510(k) number K153698.

Who is the listed applicant for LumenR Tissue Retractor System?

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

What is the FDA product code for LumenR Tissue Retractor System?

The FDA product code for LumenR Tissue Retractor System is ODB.

Related Devices (Code: ODB)

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.

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Official Source

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