Device Classification Name |
More FDA Info for this Device |
510(K) Number |
K201399 |
Device Name |
HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0░, 30░, 45░, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0░, 30░, 45░, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0░, 30░, 45░, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Opt |
Applicant |
Karl Storz-Endoscopy-America, Inc.
2151 E. Grand Avenue
El Segundo, CA 90245 US
Other 510(k) Applications for this Company
|
Contact |
Alita McElroy
Other 510(k) Applications for this Contact |
Regulation Number |
More FDA Info for this Regulation Number |
Classification Product Code |
OWN
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
05/28/2020 |
Decision Date |
08/17/2020 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
GU - Gastroenterology & Urology |
Review Advisory Committee |
SU - General & Plastic Surgery |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|