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FDA 510(k)

ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)

K-Number: K152702 · 2016-02-18

ApplicantEnt Biotech Solutions
Decision Date2016-02-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) is a medical device manufactured by Ent Biotech Solutions. It received FDA 510(k) clearance on 2016-02-18 under approval number K152702. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)?

ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) is a medical device that received FDA 510(k) clearance on 2016-02-18. It is manufactured by Ent Biotech Solutions. The 510(k) number is K152702.

When was ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) approved by the FDA?

ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) received FDA 510(k) clearance on 2016-02-18, under approval number K152702.

What company makes ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)?

ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) is manufactured by Ent Biotech Solutions.

What is the FDA product code for ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)?

The FDA product code for ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) is GEI.

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Related PubMed Literature

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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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