Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K213386 |
Device Name |
Titan Manufacturing Bipolar Forceps |
Applicant |
Titan Manufacturing, Inc. |
1 Rapps Run |
Malvern,
PA
19355
|
|
Applicant Contact |
Donald Seavey |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 10/13/2021 |
Decision Date | 10/25/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|