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FDA 510(k)

SmartRelease Endoscopic Soft Tissue Release System

K-Number: K223406 · 2023-02-02

ApplicantMicroaire Surgical Instruments
Decision Date2023-02-02
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 2023-02-02 under approval number K223406. 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 2023-02-02. It is manufactured by Microaire Surgical Instruments. The 510(k) number is K223406.

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

SmartRelease Endoscopic Soft Tissue Release System received FDA 510(k) clearance on 2023-02-02, under approval number K223406.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

Other Devices by Microaire Surgical Instruments

K192694PAL Single-Use Cannulas K211297SMARTRELEASE 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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