Who else makes this device?

Name: KIT 101
Brand: KIT 101

General & Plastic Surgery › SurgicalClip, Implantable

KIT 101

Kit Contains: CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF12, 5x100 Kii® Fios® ADVFIX DP 10/BX C0R47, 12x100 Kii®…

Registry build 21.09.26

Kit Contains: CFS02, 5×100 Kii® SLEEVE ADVFIX 12/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF12, 5×100 Kii® Fios® ADVFIX DP 10/BX C0R47, 12×100 Kii® BALLOON BLUNT TIP 6/BX

4manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Shanghai (1), Beijing (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FZP
Manufacturer	City	Province	Registered as	Device types
Hangzhou Kangji Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	27
Jiangsu Bana Medical Technology Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	4
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Beijing Zksk Technology Co., Ltd.	Beijing	Beijing	Contract manufacturer	38

Record

Regulatory record for KIT 101
Listed by	Applied Medical Resources Corp., United States
FDA product code	FZP
Device type	Clip, Implantable
Device class	Class 2
Regulation	21 CFR 878.4300
Establishment	Contract manufacturer, Complaint-file establishment, Manufacturer
Record published	2015-10-16
Record revised	2021-02-05 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for KIT 101
Catalogue number	Size	Status
K2291		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Weck	Teleflex Medical LLC	321
Teleflex	Teleflex Medical LLC	57
AtriClip™ LAA Exclusion System	Atricure, Inc.	40
Aesculap	Aesculap AG	19
Medline	Medline Industries, Inc.	15
AtriClip Flex•v	Atricure, Inc.	12
E-Pack	Ethicon, Inc.	12
AtriClip® Pro•v™ LAA Exclusion System	Atricure, Inc.	12
Titanium Ligation Clip	Vesocclude Medical, LLC	11
SLS-Clip	Vitalitec Surgical	10
SLS-Clip Vitalitec	Peters Surgical	10
MirusTM Ligating Clip	Meril Endo Surgery PVT. Ltd.	10

Showing 12 of 70. All products under Clip, Implantable

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K033024	2003-10-24
K011236	2001-05-14
K993135	1999-12-01
K964470	1997-01-22

Recalls

1 of these is 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	Closed
2016-04-01	Class II	Nonconforming Material/Component	Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.	559,274	2017-02-07

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.