| Device Type ID | 5925 |
| Device Name | Dressing, Wound, Collagen |
| 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) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | KGN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5925 |
| Device | Dressing, Wound, Collagen |
| Product Code | KGN |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACELL, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ACELL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AEON ASTRON EUROPE B.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOTIME, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLLAGEN MATRIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GEISTLICH PHARMA AG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HARBOR MEDTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INNOCOLL PHARMACEUTICALS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA LIFESCIENCES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MIROMATRIX MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MLM BIOLOGICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NOVABONE PRODUCTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRUKMYER MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TEI BIOSCIENCES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VISCUS BIOLOGICS LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 25 |
Device Operates Differently Than Expected | 6 |
Use Of Device Problem | 4 |
Improper Or Incorrect Procedure Or Method | 2 |
Insufficient Information | 2 |
Shelf Life Exceeded | 1 |
Off-Label Use | 1 |
Expiration Date Error | 1 |
Patient-Device Incompatibility | 1 |
| Total Device Problems | 43 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | AROA BIOSURGERY | II | Nov-02-2018 |
| 2 | Integra LifeSciences Corp. | II | Apr-16-2015 |
| 3 | TEI Biosciences | II | Jan-17-2018 |