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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 the device name listed in this FDA 510(k) record. The listed applicant is Ent Biotech Solutions. It received FDA 510(k) clearance on 2016-02-18 under 510(k) 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. The listed applicant is Ent Biotech Solutions. The 510(k) number is K152702.

When did ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) receive FDA 510(k) clearance?

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

Who is the listed applicant for ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)?

The FDA 510(k) record lists Ent Biotech Solutions as the applicant. This does not by itself establish the device manufacturer.

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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Official Source

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