Who else makes this device?

Name: C-QUR Centrifx
Brand: C-QUR Centrifx

C-QUR Centrifx · Mesh, Surgical, Polymeric → General & Plastic Surgery

1manufacturer

3catalogue numbers in this listing

14510(k) clearances naming this product code

5recalls on this code

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code FTL
Manufacturer	City	Province	Registered as	Device types
Shanghai Suokang Medical Implants Co., Ltd.	Shang Hai	Shanghai	Manufacturer	2

Record

Regulatory record for C-QUR Centrifx
Listed by	Atrium Medical Corporation, United States
FDA product code	FTL
Device type	Mesh, Surgical, Polymeric
Device class	Class 2
Regulation	21 CFR 878.3300
Establishment	Specification developer, Manufacturer, Exporter
510(k)	K110110
Record published	2015-09-24
Record revised	2022-06-10 (version 7)

Specifications

Specifications
MRI safety	MR Safe
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Distribution end date	2019-12-31

Catalogue Numbers

Catalogue numbers for C-QUR Centrifx
Catalogue number	Size	Status
31396		Withdrawn
31397		Withdrawn
31395		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Technical Products	Technical Products, Inc.	143
Parietex	Sofradim Production	82
DynaMesh	FEG Textiltechnik Forschungs- und Entwicklungsges. mbH	45
Symbotex	Sofradim Production	35
Silicone Sheeting Reinforced	Bentec Medical OpCo, LLC.	33
Parietene	Sofradim Production	32
C-QUR	Atrium Medical Corporation	31
ProGrip	Sofradim Production	31
Silicone Sheeting Non-Reinforced	Bentec Medical OpCo, LLC.	31
Prolite	Atrium Medical Corporation	31
Gore Seamguard Bioabsorbable Staple Line Reinforce	W. L. Gore & Associates, Inc.	30
Surgimesh®wn	Aspide Medical	28

Showing 12 of 148. All products under Mesh, Surgical, Polymeric

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K151386	2015-10-22
K151437	2015-08-27
K121070	2012-04-26
K110110	2011-02-15
K100076	2010-01-26
K090909	2009-06-04
K082748	2009-01-14
K080691	2008-04-16
K080688	2008-04-16
K070192	2007-03-08
K050311	2006-03-31
K002093	2000-07-24
K992991	2000-01-27
K930669	1993-12-16

Recalls

5 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	Closed
2017-11-22	Class II	Under Investigation by firm	An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code	60 units	2018-07-30
2013-07-19	Class II	Package design/selection	Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions	32,834 units	2016-03-18
2013-07-19	Class II	Package design/selection	Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions	15,630 units	2016-03-18
2013-07-19	Class II	Package design/selection	Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions	1501 units	2016-03-18
2013-07-19	Class II	Package design/selection	Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions	95,286 units	2016-03-18

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P990028	2003-12-04	FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT	Genzyme Corporation

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.

C-QUR Centrifx