Bard
Bard CK Parastomal Hernia Patch Size: 4.9" x 6.1", Stoma Opening Diameter 1.1" -1.4"
1manufacturer
27catalogue numbers in this listing
4510(k) clearances naming this product 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 | Davol Inc., United States |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2015-05-16 |
| Record revised | 2026-04-17 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 3, case of 2, case of 5 |
| Sizes | Length 2.5 to 30.5 cm; width 4.5 to 36 cm; length 4.9 to 17 in; width 6 to 8.1 in |
| Distribution end date | 2026-03-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0117012 | Length 4.5 cm | In distribution |
| 0112670 | Width 31 cm | In distribution |
| 0117014 | Length 6 cm | In distribution |
| 0117011 | Length 15 cm | In distribution |
| 0113710 | Width 5.9 cm | In distribution |
| 0112720 | Length 15 cm | In distribution |
| 0117013 | Length 4.5 cm | In distribution |
| 0112680 | Width 15 cm | In distribution |
| 0117016 | Width 30.5 cm | In distribution |
| 0112710 | Length 10 cm | In distribution |
| 0117010 | Width 15 cm | In distribution |
| 0117015 | Length 6 cm | In distribution |
| 0113700 | Width 5.9 cm | In distribution |
| 0112650 | Width 10 cm | In distribution |
| 0117008 | Width 10 cm | In distribution |
| 0112700 | Length 10 cm | In distribution |
| 0112640 | Width 10 cm | In distribution |
| 0112660 | Length 26 cm | In distribution |
| 0117009 | Width 15 cm | In distribution |
| 0118001 | Length 4.9 in | Withdrawn |
| 0118002 | Width 6.1 in | Withdrawn |
| 0112740 | Withdrawn | |
| 0117840 | Width 6 in | Withdrawn |
| 0118004 | Length 6.1 in | Withdrawn |
| 0117841 | Width 6 in | Withdrawn |
| 0112730 | Withdrawn | |
| 0118003 | Width 8.1 in | Withdrawn |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 |
| 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
| Clearance | Decision date |
|---|---|
| K251557 | 2025-06-12 |
| K250098 | 2025-04-09 |
| K003323 | 2001-01-22 |
| K792281 | 1979-11-27 |
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.