Device Classification NameEndoscope, Neurological510(K)...

Device Classification Name	Endoscope, Neurological
510(K) Number	K181116
Device Name	CONVIVO
Applicant	Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 Jena,  DE 07745
Applicant Contact	Christian Muenster
Correspondent	Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin,  CA  94568
Correspondent Contact	Mandy Ambrecht
Regulation Number	882.1480
Classification Product Code	GWG
Subsequent Product Code	OWN
Date Received	04/27/2018
Decision Date	10/25/2018
Decision	Substantially Equivalent (SESE)
Regulation Medical Specialty	Neurology
510k Review Panel	General & Plastic Surgery
Type	Traditional
Reviewed By Third Party	No
Combination Product	Yes

There is FDA approval. Decision date Oct 25 2018. 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181116