Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid
|
510(k) Number |
K221744 |
Device Name |
STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device |
Applicant |
Ethicon, Inc. |
1000 US-202 |
Raritan,
NJ
08869 -1425
|
|
Applicant Contact |
Jenny Wang |
Correspondent |
Ethicon, Inc. |
1000 US-202 |
Raritan,
NJ
08869 -1425
|
|
Correspondent Contact |
Jenny Wang |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 06/16/2022 |
Decision Date | 11/15/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|