Who else makes this device?

Name: Renasys AB Drsg KIT W/Softport
Brand: Renasys AB Drsg KIT W/Softport

Renasys AB Drsg KIT W/Softport · Mesh, Surgical, Polymeric → General & Plastic Surgery

1manufacturer

1catalogue number

2510(k) clearances naming this product 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 Renasys AB Drsg KIT W/Softport
Listed by	Smith & Nephew, Inc., United States
FDA product code	FTL
Device type	Mesh, Surgical, Polymeric
Device class	Class 2
Regulation	21 CFR 878.3300
Establishment	Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K143133
Record published	2020-04-24
Record revised	2023-09-07 (version 4)

Specifications

Specifications
MRI safety	MR Unsafe
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number, expiry date
Packaging	Case of 5

Catalogue Numbers

Catalogue numbers for Renasys AB Drsg KIT W/Softport
Catalogue number	Size	Status
66021980		In distribution

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
K112784	2011-11-22
K100787	2010-09-17

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.

Renasys AB Drsg KIT W/Softport