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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 a medical device manufactured by Microaire Surgical Instruments. It received FDA 510(k) clearance on 2021-06-24 under approval 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. It is manufactured by Microaire Surgical Instruments. The 510(k) number is K211297.

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

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

What company makes SMARTRELEASE Endoscopic Soft Tissue Release System?

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

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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Related PubMed Literature

PMID: 39420619 Polymer-interface-tissue model to estimate leachable release from medical devices. Mathematical medicine and biology : a journal of the IMA (2024) PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021)

Other Devices by Microaire Surgical Instruments

K192694PAL Single-Use Cannulas K223406SmartRelease Endoscopic Soft Tissue Release System

Related Devices (Code: 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.

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