ENDOCHOICE, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3007591333	3007591333	ENDOCHOICE, INC.	1	Y	2020-04-25	11810 Wills Rd Alpharetta GA US 30009

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00816849010113	Seal® - Biopsy Valve	888-632-3636	customercare@endochoice.com
00816849010120	Seal® - Biopsy Valve	888-632-3636	customercare@endochoice.com

endochoice.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
202798	1975188294	K182275	Seal Single Use Biopsy Valve	OCX	2018-09-13
202798	1326659218	K161167	Seal Single-Use Biopsy Valve	OCX	2016-05-26
202798	1500094635	K160403	SmartStart Air/Water and Suction Valves	ODC	2016-05-19
202798	1703992537	K160275	Fuse Endoscopic System with FuseBox Processor	PEA	2016-08-01
202798	1810422050	K152182	Fuse Gastroscopy System	FDS	2015-12-10
202798	1923667842	K141598	FUSE COLONOSCOPY SYSTEM	FDF	2014-09-30
202798	2006635692	K140760	BONASTENT BILIARY	FGE	2014-06-16
202798	2035499118	K140472	BONASTENT TRACHEAL / BRONCHIAL	JCT	2014-10-17
202798	1109092638	K132535	AUTOBAND LIGATOR	MND	2013-08-23
202798	1231443996	K132065	INJECTION NEEDLE	FBK	2014-01-17
202798	2026097001	K131991	ENDOCHOICE HOT BIOPSY FORCEPS	KGE	2013-10-15
202798	1721364322	K123223	EC SINGLE USE, POLYPECTOMY SNARE	FDI	2013-01-10
202798	1629492530	K112110	STERILE LUBRICATING JELLY	KMJ	2012-04-10
202798	1775217264	K111821	BIOPSY VALVE	OCX	2011-07-28
202798	1309666596	K093003	BONASTENT BILIARY	FGE	2010-03-24
202798	1517147953	K092144	BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR	ESW	2010-02-22
202798	1607830403	K083556	MODIFICATION TO AUTO-BAND LIGATOR	MND	2009-02-19
202798	1165203538
202798	1198580309
202798	1220377954
202798	1270784700
202798	1310568418
202798	1417523634
202798	1691360549
202798	1944333789

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
OCX	3	2018-09-13
FGE	2	2014-06-16
MND	2	2013-08-23
PEA	1	2016-08-01
ODC	1	2016-05-19
FDS	1	2015-12-10
JCT	1	2014-10-17
FDF	1	2014-09-30
FBK	1	2014-01-17
KGE	1	2013-10-15
FDI	1	2013-01-10
KMJ	1	2012-04-10
ESW	1	2010-02-22

PMN#

EndoChoice Water Bottle Cap Irrigation System
2016-06-27
ENDOCHOICE, INC.
Seal Single-Use Biopsy Valve
2016-05-26
ENDOCHOICE, INC.
SmartStart Air/Water And Suction Valves
2016-05-19
ENDOCHOICE, INC.
EndoChoice Water Bottle Cap System
2016-02-24
ENDOCHOICE, INC.
EndoChoice Select Injection Needle
2016-02-08
ENDOCHOICE, INC.
Rescuenet
2015-11-03
ENDOCHOICE, INC.
ENDOCHOICE WATER BOTTLE CAP SYSTEM
2015-01-20
ENDOCHOICE, INC.
BONASTENT TRACHEAL / BRONCHIAL
2014-10-17
ENDOCHOICE, INC.
FUSE COLONOSCOPY SYSTEM
2014-09-30
ENDOCHOICE, INC.
BONASTENT BILIARY
2014-06-16
ENDOCHOICE, INC.
SEAL SINGLE-USE BIOPSY VALVE
2014-03-19
ENDOCHOICE, INC.
FUSE 1C COLONOSCOPY SYSTEM
2014-02-06
ENDOCHOICE, INC.
INJECTION NEEDLE
2014-01-17
ENDOCHOICE, INC.
ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM
2014-01-08
ENDOCHOICE, INC.
SEAL BIOPSY VALVE - REUSABLE
2013-12-20
ENDOCHOICE, INC.
ENDOCHOICE HOT BIOPSY FORCEPS
2013-10-15
ENDOCHOICE, INC.
PEERSCOPE SYSTEM
2013-10-10
ENDOCHOICE, INC.
AUTOBAND LIGATOR
2013-08-23
ENDOCHOICE, INC.
EC SINGLE USE, POLYPECTOMY SNARE
2013-01-10
ENDOCHOICE, INC.
WATER BOTTLE CAP IRRIGATON SYSTEM
2012-11-27
ENDOCHOICE, INC.
ENDOCHOICE WATER BOTTLE CAP SYSTEM
2012-01-25
ENDOCHOICE, INC.
BIOPSY VALVE
2011-07-28
ENDOCHOICE, INC.
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS
2010-08-05
ENDOCHOICE, INC.
BONASTENT BILIARY
2010-03-24
ENDOCHOICE, INC.
BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR
2010-02-22
ENDOCHOICE, INC.

GUDID#

Seal® - Biopsy Valve
ENDOCHOICE, INC.
2017-11-06
Seal® - Biopsy Valve
ENDOCHOICE, INC.
2016-09-08
Seal® - Biopsy Valve
ENDOCHOICE, INC.
2016-09-08
Seal® - Biopsy Valve
ENDOCHOICE, INC.
2016-09-08
FuseBox - Endoscopic video image processor
ENDOCHOICE, INC.
2017-08-11
FuseBox - Endoscopic Video Processor Unit
ENDOCHOICE, INC.
2017-08-11
FuseBox - Endoscopic Video Processor Unit
ENDOCHOICE, INC.
2017-08-11
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Fuse C38 Colonoscope (150 cm)
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Gastroscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Gastroscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Gastroscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Gastroscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Colonoscope
ENDOCHOICE, INC.
2016-09-08
Fuse® - Gastroscope
ENDOCHOICE, INC.
2016-09-08

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