Who else makes this device?

Name: TA 90 B
Brand: TA 90 B

TA 90 B · Staple, Implantable → General & Plastic Surgery

16manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Shanghai (5), Jiangsu (5), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GDW
Manufacturer	City	Province	Registered as	Device types
Hangzhou Fushan Medical Appliance Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	44
Sterigenics Shanghai ETO Ltd.	Shanghai	Shanghai	Contract manufacturer	65
Zhangjiagang Municipal Cnnc Huakang Radiation Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	17
Covidien Medical Products (Shanghai) Manufacturing LLC	Shanghai	Shanghai	Contract manufacturer	8
Beijing Biosis Healing Biological Technology Co., Ltd.	Beijing	Beijing	Manufacturer	7
B.j.zh.f.panther Medical Equipment Co., Ltd.	Beijing	Beijing	Manufacturer	6
Touchstone International Medical Science Co., Ltd.	Suzhou	Jiangsu	Manufacturer	5
Sinolinks Medical Innovation, Inc.	Changzhou	Jiangsu	Complaint-file establishment	5
Victor Medical Instruments Co., Ltd.	Changzhou	Jiangsu	Manufacturer	5
Lucky Star Lrradiation Science Co., Ltd. Shanghai	Shanghai	Shanghai	Contract manufacturer	5
Fengh Medical Co., Ltd.	Jiangyin	Jiangsu	Manufacturer	4
Medtronic (Shanghai) Medical Technology Co., Ltd.	Min Hang District	Shanghai	Specification developer	4

Showing 12 of 16. All 16 manufacturers in China registered for Staple, Implantable

Record

Regulatory record for TA 90 B
Listed by	Covidien LP, United States
FDA product code	GDW
Device type	Staple, Implantable
Device class	Class 2
Regulation	21 CFR 878.4750
510(k)	K855047
Record published	2015-08-28
Record revised	2025-09-18 (version 9)

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
Storage	Handling environment temperature up to 130 °F
Packaging	Case of 6
Sizes	Length 90 mm; height 4.8 mm
Distribution end date	2025-08-29

Catalogue Numbers

Catalogue numbers for TA 90 B
Catalogue number	Size	Status
015888L	Length 90 mm	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Endo GIA	Covidien LP	51
Aeon	Lexington Medical, Inc.	48
Proximate	Ethicon Endo-Surgery, Inc.	42
Tri-Staple 2.0	Covidien LP	42
EEA	Covidien LP	37
Echelon Endopath	Ethicon Endo-Surgery, Inc.	33
Reloading Unit for Endo Linear Cutter Stapler	B.j.zh.f.panther Medical Equipment Co., Ltd.	28
GIA	Covidien LP	24
easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use	Ezisurg Medical Co., Ltd.	23
Circular Stapler	B.j.zh.f.panther Medical Equipment Co., Ltd.	23
Endopath	Ethicon Endo-Surgery, Inc.	22
Signia	Covidien LP	19

Showing 12 of 105. All products under Staple, Implantable

Recalls Naming This Product

5 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of TA 90 B
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Covidien	510(k) number	2012-05-09	Class II	Package design/selection	Potential for the sterility barrier to be compromised.	50698 units	2014-02-12
Covidien	510(k) number	2012-05-09	Class II	Package design/selection	Potential for the sterility barrier to be compromised.	13531 units	2014-02-12
Covidien	510(k) number	2012-05-09	Class II	Package design/selection	Potential for the sterility barrier to be compromised.	13531 units	2014-02-12
Covidien	510(k) number	2012-05-09	Class II	Package design/selection	Potential for the sterility barrier to be compromised.	28248 units	2014-02-12
Covidien	510(k) number	2012-05-09	Class II	Package design/selection	Potential for the sterility barrier to be compromised.	17848 units	2014-02-12

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.

TA 90 B