Prolite
ProLite Mesh L, 1.5in. x 2.5in. (3.8cm x 6.4cm), 5in. (12.5cm)
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) | K151437 |
| Record published | 2015-09-24 |
| Record revised | 2025-08-18 (version 9) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6, pack of 5, pack of 4, pack of 12 |
| Distribution end date | 2019-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1010306-01 | Withdrawn | |
| 1010101-01 | Withdrawn | |
| 1010306-06 | Withdrawn | |
| 1010303-06 | Withdrawn | |
| 1010101-05 | Withdrawn | |
| 1000103-00 | Withdrawn | |
| 1000204-01 | Withdrawn | |
| 1000212-00 | Withdrawn | |
| 1010404-01 | Withdrawn | |
| 1010202-01 | Withdrawn | |
| 1010303-01 | Withdrawn | |
| 1010204-02 | Withdrawn | |
| 1010306-05 | Withdrawn | |
| 1010405-02 | Withdrawn | |
| 1010202-05 | Withdrawn | |
| 1001014-00 | Withdrawn | |
| 1010306-04 | Withdrawn | |
| 1010404-05 | Withdrawn | |
| 1000104-00 | Withdrawn | |
| 1010303-05 | Withdrawn | |
| 1010405-01 | Withdrawn | |
| 1000609-00 | Withdrawn | |
| 1001212-00 | Withdrawn | |
| 1000407-00 | Withdrawn | |
| 1010306-02 | Withdrawn | |
| 1000406-00 | Withdrawn | |
| 1000306-00 | Withdrawn | |
| 1000303-00 | Withdrawn | |
| 1000606-00 | Withdrawn | |
| 1001218-00 | Withdrawn | |
| 1000204-00 | Withdrawn |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 |
| C-QUR | Atrium Medical Corporation | 31 |
| ProGrip | Sofradim Production | 31 |
| Silicone Sheeting Non-Reinforced | Bentec Medical OpCo, LLC. | 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
1 recall names this product by its own identifier, 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 | 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 |
Recalls
4 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 |
|---|---|---|---|---|---|
| 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.
| 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.