| Device Type ID | 5528 |
| Device Name | Mesh, Surgical |
| Regulation Description | Surgical Mesh. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FTM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5528 |
| Device | Mesh, Surgical |
| Product Code | FTM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACELL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ACELL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ALLERGAN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLLAFIRM LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLORADO THERAPEUTICS LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COOK BIOTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
CORMATRIX CARDIOVASCULAR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CURASEAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FLEXTRONICS INTERNATIONAL USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA LIFESCIENCES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIFECELL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MIROMATRIX MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RTI SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TEI BIOSCIENCES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELA BIO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TISSUE REGENIX GROUP PLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 693 |
Adverse Event Without Identified Device Or Use Problem | 492 |
Insufficient Information | 249 |
Migration Or Expulsion Of Device | 198 |
Device Operates Differently Than Expected | 23 |
Migration | 18 |
Degraded | 15 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 10 |
Microbial Contamination Of Device | 9 |
Defective Device | 9 |
Material Erosion | 9 |
Hole In Material | 8 |
Contamination During Use | 8 |
Material Disintegration | 7 |
Material Rupture | 7 |
Split | 6 |
Break | 4 |
Patient Device Interaction Problem | 4 |
Device Contamination With Biological Material | 4 |
Detachment Of Device Component | 3 |
Material Deformation | 3 |
Material Perforation | 3 |
Torn Material | 3 |
Mechanics Altered | 3 |
Device Appears To Trigger Rejection | 3 |
Material Split, Cut Or Torn | 3 |
Device Dislodged Or Dislocated | 3 |
No Apparent Adverse Event | 3 |
Delamination | 2 |
Product Quality Problem | 2 |
Failure To Adhere Or Bond | 2 |
Flaked | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Device Emits Odor | 2 |
Material Too Rigid Or Stiff | 1 |
Material Separation | 1 |
Incomplete Or Missing Packaging | 1 |
Device Issue | 1 |
Failure To Form Staple | 1 |
Device Packaging Compromised | 1 |
Material Protrusion / Extrusion | 1 |
Ring | 1 |
Peeled / Delaminated | 1 |
Unintended Movement | 1 |
Shelf Life Exceeded | 1 |
Failure To Unfold Or Unwrap | 1 |
Device Expiration Issue | 1 |
Device Or Device Fragments Location Unknown | 1 |
Missing Value Reason | 1 |
Entrapment Of Device | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Material Integrity Problem | 1 |
Calcified | 1 |
Human-Device Interface Problem | 1 |
Difficult To Open Or Close | 1 |
Explanted | 1 |
Use Of Device Problem | 1 |
Loss Of Or Failure To Bond | 1 |
| Total Device Problems | 1838 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ACell, Inc | II | Mar-21-2019 |
| 2 | AROA Biosurgery, LTD. | II | Nov-09-2018 |
| 3 | Ethicon, Inc. | II | Apr-03-2014 |