C-QUR
C-QUR FX, 5.7 in. x 4.1 in. (14.6 cm x 10.5 cm) 3D-LAPPATCH, W/HOLE,MED
1manufacturer
31catalogue numbers in this listing
14510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Suokang Medical Implants Co., Ltd. | Shang Hai | Shanghai | Manufacturer | 2 |
Record
| 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) | K082748 |
| Record published | 2015-09-24 |
| Record revised | 2022-06-10 (version 7) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Pack of 6 |
| Distribution end date | 2019-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31322 | Withdrawn | |
| 31591 | Withdrawn | |
| 31340 | Withdrawn | |
| 31543 | Withdrawn | |
| 31542 | Withdrawn | |
| 31342 | Withdrawn | |
| 31324 | Withdrawn | |
| 31535 | Withdrawn | |
| 31544 | Withdrawn | |
| 31385 | Withdrawn | |
| 31388 | Withdrawn | |
| 31527 | Withdrawn | |
| 31528 | Withdrawn | |
| 31526 | Withdrawn | |
| 31326 | Withdrawn | |
| 31311 | Withdrawn | |
| 31312 | Withdrawn | |
| 31507 | Withdrawn | |
| 31533 | Withdrawn | |
| 31328 | Withdrawn | |
| 31537 | Withdrawn | |
| 31540 | Withdrawn | |
| 31341 | Withdrawn | |
| 31538 | Withdrawn | |
| 31332 | Withdrawn | |
| 31536 | Withdrawn | |
| 31336 | Withdrawn | |
| 31505 | Withdrawn | |
| 31506 | Withdrawn | |
| 31534 | Withdrawn | |
| 31531 | Withdrawn |
Same 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 |
| 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 |
| Bard | Davol Inc. | 27 |
Showing 12 of 148. All products under Mesh, Surgical, Polymeric
510(K) Clearances
| 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 Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Atrium Medical Corporation | 510(k) number | 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 |
| Atrium Medical Corporation | 510(k) number | 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 |
Recalls
3 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.
| 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 | 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 | 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.
| 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.