Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K112349 |
Device Name |
VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR |
Applicant |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
60 Middletown Ave |
North Haven,
CT
06473
|
|
Applicant Contact |
ANGELA V ARSDALE |
Correspondent |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
60 Middletown Ave |
North Haven,
CT
06473
|
|
Correspondent Contact |
ANGELA V ARSDALE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/16/2011 |
Decision Date | 09/01/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|