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FDA 510(k)

SMARTRELEASE Endoscopic Soft Tissue Release System

K-Number: K211297 · 2021-06-24

ApplicantMicroaire Surgical Instruments
Decision Date2021-06-24
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMARTRELEASE Endoscopic Soft Tissue Release System is the device name listed in this FDA 510(k) record. The listed applicant is Microaire Surgical Instruments. It received FDA 510(k) clearance on 2021-06-24 under 510(k) number K211297. 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 2021-06-24. The listed applicant is Microaire Surgical Instruments. The 510(k) number is K211297.

When did SMARTRELEASE Endoscopic Soft Tissue Release System receive FDA 510(k) clearance?

SMARTRELEASE Endoscopic Soft Tissue Release System received FDA 510(k) clearance on 2021-06-24, under 510(k) number K211297.

Who is the listed applicant for SMARTRELEASE Endoscopic Soft Tissue Release System?

The FDA 510(k) record lists Microaire Surgical Instruments as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

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Other records listing Microaire Surgical Instruments as applicant

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.

K243589PAL Sterilization CaseK244026PAL 7020 ConsoleK242804PAL Aspiration SystemK223406SmartRelease Endoscopic Soft Tissue Release SystemK220318PAL Infiltration SystemK212024PAL System

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Related Devices (Code: HRX)

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.

K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)K250795PUREVUE™ FMSW.O.M. World of Medicine GmbHK252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC

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.

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