Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K233346 |
Device Name |
Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinr |
Applicant |
HG Innovations Ltd |
5 Elder Court, Lions Drive |
Shadsworth Business Park, Blackburn |
Lancashire,
GB
BB1 2EQ
|
|
Applicant Contact |
M Umran Rafiq |
Correspondent |
Medical Device Academy, Inc |
345 Lincoln Hill Road |
Shrewsbury,
VT
05738
|
|
Correspondent Contact |
Wondwossen Tekolla |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/29/2023 |
Decision Date | 11/20/2023 |
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 |
No
|
|
|