Cleared Traditional

SMARTRELEASE Endoscopic Soft Tissue Release System

K181819 · Microaire Surgical Instruments, LLC · General Hospital

Nov 2018

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K181819 is an FDA 510(k) clearance for the SMARTRELEASE Endoscopic Soft Tissue Release System, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Microaire Surgical Instruments, LLC (Charlottesville, US). The FDA issued a Cleared decision on November 6, 2018, 120 days after receiving the submission on July 9, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K181819 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 2018
Decision Date	November 06, 2018
Days to Decision	120 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).