FDA 510(k)

SMARTRELEASE Endoscopic Soft Tissue Release System

K-Number: K181819 · 2018-11-06

ApplicantMicroaire Surgical Instruments, LLC

Decision Date2018-11-06

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SMARTRELEASE Endoscopic Soft Tissue Release System is a medical device manufactured by Microaire Surgical Instruments, LLC. It received FDA 510(k) clearance on 2018-11-06 under approval number K181819. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTRELEASE Endoscopic Soft Tissue Release System?

SMARTRELEASE Endoscopic Soft Tissue Release System is a medical device that received FDA 510(k) clearance on 2018-11-06. It is manufactured by Microaire Surgical Instruments, LLC. The 510(k) number is K181819.

When was SMARTRELEASE Endoscopic Soft Tissue Release System approved by the FDA?

SMARTRELEASE Endoscopic Soft Tissue Release System received FDA 510(k) clearance on 2018-11-06, under approval number K181819.

What company makes SMARTRELEASE Endoscopic Soft Tissue Release System?

SMARTRELEASE Endoscopic Soft Tissue Release System is manufactured by Microaire Surgical Instruments, LLC.

What is the FDA product code for SMARTRELEASE Endoscopic Soft Tissue Release System?

The FDA product code for SMARTRELEASE Endoscopic Soft Tissue Release System is HRX.

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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.