Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K193315 |
Device Name |
Xenocor Articulating Xenoscope Laparoscope |
Applicant |
Xenocor, Inc |
630 Komas Dr. Suite 200 |
Salt Lake City,
UT
84108
|
|
Applicant Contact |
Evan Kelso |
Correspondent |
University of Utah |
10 North 1900 East, EHSL Rm, 22B |
Salt Lake City,
UT
84112
|
|
Correspondent Contact |
Spencer Walker |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/29/2019 |
Decision Date | 01/27/2020 |
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
|
|
|