Definition: Docket Number: 2006p-0071 - May 5, 2008 - Reclassified From Class 3 Pma To Class 2 510(k).
| Device Type ID | 5750 |
| Device Name | Tissue Adhesive For The Topical Approximation Of Skin |
| Regulation Description | Tissue Adhesive. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MPN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5750 |
| Device | Tissue Adhesive For The Topical Approximation Of Skin |
| Product Code | MPN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tissue Adhesive. |
| CFR Regulation Number | 878.4010 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADHEZION BIOMEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
ADVANCED MEDICAL SOLUTIONS GROUP PLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AESCULAP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BERGEN MEDICAL PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CHEMENCE MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CHEMENCE MEDICAL PRODUCTS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLUSTITCH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OPTMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 196 |
Break | 172 |
Fluid Leak | 72 |
Crack | 55 |
Adverse Event Without Identified Device Or Use Problem | 45 |
Material Integrity Problem | 39 |
Partial Blockage | 38 |
Gel Leak | 30 |
Leak / Splash | 16 |
Failure To Adhere Or Bond | 15 |
Material Twisted / Bent | 14 |
Device Operates Differently Than Expected | 11 |
Product Quality Problem | 11 |
Packaging Problem | 11 |
Component Missing | 9 |
Insufficient Cooling | 8 |
Tear, Rip Or Hole In Device Packaging | 8 |
Insufficient Information | 8 |
No Flow | 7 |
Bent | 5 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 5 |
Device Markings / Labelling Problem | 5 |
Reaction | 4 |
Unsealed Device Packaging | 4 |
Incomplete Or Missing Packaging | 4 |
Material Discolored | 4 |
Clumping In Device Or Device Ingredient | 3 |
Chemical Problem | 3 |
Defective Device | 3 |
Thermal Decomposition Of Device | 2 |
Moisture Or Humidity Problem | 2 |
Complete Blockage | 2 |
Device Misassembled During Manufacturing / Shipping | 2 |
Crystal | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
Label | 1 |
Tip | 1 |
Poor Quality Image | 1 |
Detachment Of Device Component | 1 |
Hole In Material | 1 |
Out-Of-Box Failure | 1 |
Detachment Of Device Or Device Component | 1 |
Improper Flow Or Infusion | 1 |
Hermetic Seal | 1 |
| Total Device Problems | 825 |