Cleared Special

mi-eye 3 needlescope with cannula, mi-tablet 3

K212556 · Trice Medical, Inc. · Orthopedic

Sep 2021

Decision

33d

Days

Class 2

Risk

About This 510(k) Submission

K212556 is an FDA 510(k) clearance for the mi-eye 3 needlescope with cannula, mi-tablet 3, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Trice Medical, Inc. (Malvern, US). The FDA issued a Cleared decision on September 15, 2021, 33 days after receiving the submission on August 13, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K212556 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 2021
Decision Date	September 15, 2021
Days to Decision	33 days
Submission Type	Special
Review Panel	Orthopedic (OR)
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).