What is FDA product code HRX?

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).

Orthopedic › DiagnosticArthroscope

Mi-Eye 2 95mm

Name: mi-eye 2 95mm
Brand: mi-eye 2 95mm

The 95 mm mi-eye 2 probe provides illumination and visualization inside a body cavity during diagnostic or operative arthroscopic and endoscopic procedures. It is a sterile single use probe…

Registry build 21.09.26

The 95 mm mi-eye 2 probe provides illumination and visualization inside a body cavity during diagnostic or operative arthroscopic and endoscopic procedures. It is a sterile single use probe that can enter through a natural or surgically created opening.

A camera, light emitting diode source and imaging optics sit at the distal tip of a rigid shaft. A cable connects the probe to a separate display, which supplies power and shows real time video from the camera.

Listed Item

mi-eye 2 probe 95mm length for use with Trice Tablet 2

Access Features

The shaft extends from a handle and includes a retractable needle. A flushing port allows the field of view to be cleared during use. The 95 mm version is one of three probe lengths sharing the same design and function.

21manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (7), Jiangsu (6), Guangdong (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HRX
Manufacturer	City	Province	Registered as	Device types
Modern Medical Equipment Manufacturing Ltd.	Heng Li, Dongguan	Guangdong	Contract manufacturer	26
Dongguan BAO Kang Dian ZI KE JI Limited	Dongguan	Guangdong	Contract manufacturer	24
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Peter’s Technology (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	9
Jiangsu Shenli Medical Production Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	6
PAN-International Precision Electronic Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	4
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53
Hangzhou Fushan Medical Appliance Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	44
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38
Goals Sterilization Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	26

Showing 12 of 21. All 21 manufacturers in China registered for Arthroscope

Record

Regulatory record for mi-eye 2 95mm
Listed by	Trice Medical, United States
FDA product code	HRX
Device type	Arthroscope
Device class	Class 2
Regulation	21 CFR 888.1100
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K162475
Record published	2017-06-09
Record revised	2025-03-03 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Sizes	Length 95 mm
Distribution end date	2025-02-28

Catalogue Numbers

Catalogue numbers for mi-eye 2 95mm
Catalogue number	Size	Status
T200-095	Length 95 mm	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Surgical Direct	Surgical Direct, Inc.	299
Arthroscope	Karl Storz GmbH & Co. KG	278
Conmed/Linvatec	Provision	265
Arthroscope	Smith & Nephew, Inc.	255
Medline	Medline Industries, Inc.	205
Arthroscope	Sterilmed, Inc.	184
Sustainable Technologies	Provision	150
Medline Renewal	Medline Industries, Inc.	123
Stryker	Provision	113
Arthrex®	Arthrex, Inc.	109
Arthrex	Provision	109
Eberle	Eberle GmbH & Co. KG	92

Showing 12 of 567. All products under Arthroscope

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K212556	2021-09-15
K162475	2016-09-16
K141119	2014-07-29

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.