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).

Shaver Interface Box B1 · Arthroscope → Orthopedic

Name: Shaver Interface Box B1
Brand: Shaver Interface Box B1

21manufacturers in China registered for this device type

1catalogue number

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 Shaver Interface Box B1
Listed by	Insightra Medical, Inc., United States
FDA product code	HRX
Device type	Arthroscope
Device class	Class 2
Regulation	21 CFR 888.1100
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K093409
Record published	2016-09-24
Record revised	2021-05-27 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Shaver Interface Box B1
Catalogue number	Size	Status
1407200		In distribution

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

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Shaver Interface Box B1
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Vision Medical Inc	510(k) number	2016-05-10	Class II	Unknown/Undetermined by firm	Sterility of device may be compromised due to sterile package breakage.	3,295 devices	2017-09-18

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.

Shaver Interface Box B1