Who else makes this device?

Name: BiSurge
Brand: BiSurge

General & Plastic Surgery › SurgicalCannula, Surgical, General & Plastic Surgery

BiSurge

4 catalogue numbers from 620-163-920, listed by Genicon, Inc., United States, under Cannula, Surgical, General & Plastic Surgery. 14 manufacturers in China are registered for this product code.

Registry build 21.09.26

14manufacturers in China registered for this device type

4catalogue numbers in this listing

14recalls on this code

Who Else Makes It

Concentrated in Zhejiang (7), Shanghai (3), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GEA
Manufacturer	City	Province	Registered as	Device types
Ningbo Luke Medical Devices Co., Ltd.	Yuyao	Zhejiang	Contract manufacturer	27
Shanghai KiNETIC Medical Co Ltd	Shanghai	Shanghai	Contract manufacturer	19
Shanghai Kindly Enterprise Development Group Co., Ltd.	Jiading	Shanghai	Contract manufacturer	11
Boen Healthcare Co., Ltd.	Suzhou	Jiangsu	Specification developer	263
Shanghai Medical Instruments (Group) Ltd. Corp.	Shanghai	Shanghai	Contract manufacturer	235
Xinhua Surgical Instrument Co., Ltd.	Zibo	Shandong	Manufacturer	222
Ningbo Chibanda IMP &EXP Co., Ltd.	Ningbo	Zhejiang	Manufacturer	59
Premium Plus (Dongguan) Limited	Dongguan	Guangdong	Repacker / relabeller	34
Beijing Fule Science & Technology Development Co., Ltd.	Beijing	Beijing	Manufacturer	31
Hangzhou Kangji Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	27
Ningbo Hanyue Medical Technology Co., Ltd.	Cixi	Zhejiang	Contract manufacturer	27
Tonglu Wanhe Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	24

Showing 12 of 14. All 14 manufacturers in China registered for Cannula, Surgical, General & Plastic Surgery

Record

Regulatory record for BiSurge
Listed by	Genicon, Inc., United States
FDA product code	GEA
Device type	Cannula, Surgical, General & Plastic Surgery
Device class	Class 1
Regulation	21 CFR 878.4800
510(k)	K041968
Record published	2017-10-11
Record revised	2020-01-09 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for BiSurge
Catalogue number	Size	Status
620-163-920		In distribution
628-163-950		In distribution
620-163-950		In distribution
628-163-920		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cannula, Surgical, General & Plastic Surgery	Black & Black Surgical, Inc.	1,600
Summit Medical	Summit Medical LLC	988
Medco Manufacturing	Medco Manufacturing LLC	562
Hayden Medical	Hayden Medical Inc	457
Cannula, Surgical, General & Plastic Surgery	Shippert Medical Technologies Corp.	452
Boss Instruments	Boss Instruments, Ltd.	436
Millennium	Avalign Technologies, Inc.	281
Black & Black Surgical	Black & Black Surgical, Inc.	227
Alira Medical Devices	Alira Medical Devices LLC	157
Black & Black Surgical, Inc.	Black & Black Surgical, Inc.	154
Aesculap	Aesculap AG	134
Euromi	Euromi	126

Showing 12 of 608. All products under Cannula, Surgical, General & Plastic Surgery

Recalls

14 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	17 boxes (5 units per box)
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	48 boxes (5 units per box)
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	2 boxes (5 units per box)
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	12 boxes (5 units per box)
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	106 boxes (5 units per box)
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	74 boxes (5 units per box)
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	378 boxes (5 units per box)
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	0 (24 boxes with 5 units/box in inventory)
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	10 boxes (5 units per box)
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	102 boxes (5 units per box)
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	3 box (5 units per box)
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	0 (6 boxes with 5 units/per box in inventory)
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	42 boxes (5 units per box)
2018-08-21	Class II	Process control	There is potential for the plastic optical tip to become detached from the metal shaft.	28 boxes (5 units per box)

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.