Endochoice Inc

FDA Filings

This page includes the latest FDA filings for Endochoice Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007591333
• FEI Number: 3007591333
• Name: ENDOCHOICE, INC.
• Owner & Operator: Boston Scientific Corporation
• Contact Address: 300 Boston Scientific Way ; Marlborough MA 01752 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 11810 Wills Rd ; Alpharetta, GA 30009 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 10840253110067 ENDOCHOICE, INC.	Seal®	2023-06-27
GUDID 00840253111180 ENDOCHOICE, INC.	Fuse SCT-469-02	2019-11-27
GUDID 00840253111173 ENDOCHOICE, INC.	Fuse SCT-468-02	2019-11-27
GUDID 00840253101228 ENDOCHOICE, INC.	Fuse®	2019-11-27
GUDID 00840253101211 ENDOCHOICE, INC.	Fuse®	2019-11-27
GUDID 00816849017341 ENDOCHOICE, INC.	Rescue®	2019-08-21
GUDID 00816849017334 ENDOCHOICE, INC.	Rescue®	2019-08-21
GUDID 00816849017327 ENDOCHOICE, INC.	Rescue®	2019-08-21
GUDID 00816849017310 ENDOCHOICE, INC.	Rescue®	2019-08-21
GUDID 00816849017303 ENDOCHOICE, INC.	Rescue®	2019-08-21
GUDID 00840253114327 ENDOCHOICE, INC.	FuseBox FSP-100-AR-R	2019-02-21
GUDID 00840253114310 ENDOCHOICE, INC.	FuseBox FSP-100-R	2019-02-21
GUDID 00840253104274 ENDOCHOICE, INC.	FuseBox LS-FSP-100-AR	2019-02-21
GUDID 00840253104267 ENDOCHOICE, INC.	FuseBox LS-FSP-100	2019-02-21
GUDID 00840253103932 ENDOCHOICE, INC.	FuseBox FSP-100-AR	2019-02-21
GUDID 00816849019680 ENDOCHOICE, INC.	Fuse®	2019-02-21
KMJ ENDOCHOICE, INC. [Boston Scientific Corporation]	Sterile Lubricating Jelly	2018-12-07
GUDID 00840253114594 ENDOCHOICE, INC.	Fuse FSG-2500-ST-R	2018-06-21
GUDID 00840253114587 ENDOCHOICE, INC.	Fuse FSG-2500-MC90-R	2018-06-21
GUDID 00840253114570 ENDOCHOICE, INC.	Fuse FSC330-C6339-R	2018-06-21
GUDID 00840253114563 ENDOCHOICE, INC.	Fuse FSC330-C6338-R	2018-06-21
GUDID 00840253114556 ENDOCHOICE, INC.	Fuse FSC330-C6337-R	2018-06-21
GUDID 00840253114549 ENDOCHOICE, INC.	Fuse FSC330-C6333-R	2018-06-21
GUDID 00840253114532 ENDOCHOICE, INC.	Fuse FSC330-C6332-R	2018-06-21
GUDID 00840253114525 ENDOCHOICE, INC.	Fuse FSC330-A6336-R	2018-06-21
GUDID 00840253114518 ENDOCHOICE, INC.	Fuse FSC330-A6334-R	2018-06-21
GUDID 00840253114501 ENDOCHOICE, INC.	Fuse FSC-3300-ST-R	2018-06-21
GUDID 00840253114495 ENDOCHOICE, INC.	Fuse FSC-3300-SL-R	2018-06-21
GUDID 00840253114488 ENDOCHOICE, INC.	Fuse FSC-3300-150-R	2018-06-21
GUDID 00840253114471 ENDOCHOICE, INC.	Fuse FSC-3300-133-R	2018-06-21
GUDID 00840253114464 ENDOCHOICE, INC.	Fuse FSG250-H7642-R	2018-06-21
GUDID 00840253114457 ENDOCHOICE, INC.	Fuse FSG250-H7641-R	2018-06-21
GUDID 00840253114440 ENDOCHOICE, INC.	Fuse FSC330-G7529-R	2018-06-21
GUDID 00840253114433 ENDOCHOICE, INC.	Fuse FSC330-G7522-R	2018-06-21
GUDID 00840253114426 ENDOCHOICE, INC.	Fuse FSC330-G7521-R	2018-06-21
GUDID 00840253114419 ENDOCHOICE, INC.	Fuse FSC330-G7520-R	2018-06-21
GUDID 00840253114402 ENDOCHOICE, INC.	Fuse FSC330-F7526-R	2018-06-21
GUDID 00840253114396 ENDOCHOICE, INC.	Fuse FSC330-F7525-R	2018-06-21
GUDID 00840253114389 ENDOCHOICE, INC.	Fuse FSC330-F7524-R	2018-06-21
GUDID 00840253114372 ENDOCHOICE, INC.	Fuse FSC330-F7523-R	2018-06-21
GUDID 00840253111142 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253111135 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253111128 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253111111 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253111104 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253111098 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253111081 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253111074 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253111067 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253111050 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253111043 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253110848 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253110831 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253110824 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253110817 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253110800 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253110794 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253110046 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109927 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109910 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109866 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109859 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109842 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109835 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109828 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109811 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109606 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109590 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109583 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109576 ENDOCHOICE, INC.	Fuse® FSC330-F7528	2018-06-21
GUDID 00840253109552 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109545 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109538 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253109521 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00840253101068 ENDOCHOICE, INC.	Seal®	2018-06-21
GUDID 00816849019666 ENDOCHOICE, INC.	Fuse®	2018-06-21
GUDID 00816849019277 ENDOCHOICE, INC.	Neptune®	2018-06-21
GUDID 00816849019253 ENDOCHOICE, INC.	Neptune®	2018-06-21
GUDID 00816849017600 ENDOCHOICE, INC.	Boa®	2018-06-21
GUDID 00816849010120 ENDOCHOICE, INC.	Seal®	2018-06-21
GUDID 00816849010113 ENDOCHOICE, INC.	Seal®	2018-06-21
GUDID 00816849010038 ENDOCHOICE, INC.	Auto-Band®	2018-06-21
GUDID 00816849010021 ENDOCHOICE, INC.	Auto-Band®	2018-06-21
GUDID 00816849010014 ENDOCHOICE, INC.	Auto-Band®	2018-06-21
GUDID 00816849010007 ENDOCHOICE, INC.	Auto-Band®	2018-06-21
GAZ ENDOCHOICE, INC. [Boston Scientific Corporation]	Suction Tubing	2016-12-23
OEA ENDOCHOICE, INC. [Boston Scientific Corporation]	EndoArmor+ Gown	2016-12-22
OEA ENDOCHOICE, INC. [Boston Scientific Corporation]	EndoArmor Gown	2016-12-22
NAB ENDOCHOICE, INC. [Boston Scientific Corporation]	Gauze	2016-12-22
KME ENDOCHOICE, INC. [Boston Scientific Corporation]	Cinchpad	2016-12-22
PMN K160275 EndoChoice Inc.	Fuse Endoscopic System With FuseBox Processor	2016-08-01
PMN K161482 ENDOCHOICE, INC.	EndoChoice Water Bottle Cap Irrigation System	2016-06-27
PMN K161167 ENDOCHOICE, INC.	Seal Single-Use Biopsy Valve	2016-05-26
PMN K160403 ENDOCHOICE, INC.	SmartStart Air/Water And Suction Valves	2016-05-19
PMN K153588 ENDOCHOICE, INC.	EndoChoice Water Bottle Cap System	2016-02-24
PMN K151475 ENDOCHOICE, INC.	EndoChoice Select Injection Needle	2016-02-08
PMN K152182 ENDOCHOICE INC.	Fuse Gastroscopy System	2015-12-10
PMN K152580 ENDOCHOICE, INC.	Rescuenet	2015-11-03
PMN K142155 ENDOCHOICE, INC.	ENDOCHOICE WATER BOTTLE CAP SYSTEM	2015-01-20
PMN K140472 ENDOCHOICE, INC.	BONASTENT TRACHEAL / BRONCHIAL	2014-10-17
PMN K141598 ENDOCHOICE, INC.	FUSE COLONOSCOPY SYSTEM	2014-09-30
PMN K140760 ENDOCHOICE, INC.	BONASTENT BILIARY	2014-06-16
PMN K133734 ENDOCHOICE, INC.	SEAL SINGLE-USE BIOPSY VALVE	2014-03-19
PMN K132839 ENDOCHOICE, INC.	FUSE 1C COLONOSCOPY SYSTEM	2014-02-06
PMN K132065 ENDOCHOICE, INC.	INJECTION NEEDLE	2014-01-17
PMN K133747 ENDOCHOICE, INC.	ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM	2014-01-08
PMN K132776 ENDOCHOICE, INC.	SEAL BIOPSY VALVE - REUSABLE	2013-12-20
PMN K131991 ENDOCHOICE, INC.	ENDOCHOICE HOT BIOPSY FORCEPS	2013-10-15
PMN K131422 ENDOCHOICE, INC.	PEERSCOPE SYSTEM	2013-10-10
PMN K132535 ENDOCHOICE, INC.	AUTOBAND LIGATOR	2013-08-23
PMN K123223 ENDOCHOICE, INC.	EC SINGLE USE, POLYPECTOMY SNARE	2013-01-10
PMN K120862 ENDOCHOICE, INC.	WATER BOTTLE CAP IRRIGATON SYSTEM	2012-11-27
PMN K112576 ENDOCHOICE, INC.	ENDOCHOICE WATER BOTTLE CAP SYSTEM	2012-01-25
PMN K111821 ENDOCHOICE, INC.	BIOPSY VALVE	2011-07-28
PMN K101298 ENDOCHOICE, INC.	ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS	2010-08-05
PMN K093003 ENDOCHOICE, INC.	BONASTENT BILIARY	2010-03-24
PMN K092144 ENDOCHOICE, INC.	BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR	2010-02-22
KYZ ENDOCHOICE, INC. [Boston Scientific Corporation]	Syringe	2008-01-15
KYZ ENDOCHOICE, INC. [Boston Scientific Corporation]	Rapid Refill Continuous Injection System	2008-01-15
FCL ENDOCHOICE, INC. [Boston Scientific Corporation]	SpyBite	2004-09-13
FCL ENDOCHOICE, INC. [Boston Scientific Corporation]	SpyBite Max	2004-09-13
FCL ENDOCHOICE, INC. [Boston Scientific Corporation]	Radial Jaw 4 Single-Use Biopsey Forceps	2004-09-13
FCL ENDOCHOICE, INC. [Boston Scientific Corporation]	Piranha Ureteroscopic Biopsy Forceps	2004-09-13
FCL ENDOCHOICE, INC. [Boston Scientific Corporation]	Multibite	2004-09-13
MNK ENDOCHOICE, INC. [Boston Scientific Corporation]	Blox	2001-10-11

Related Finance Registrations

NCAGE Code	57HH3	ENDOCHOICE, INC.!DBA ENDO CHOICE PATHOLOGY
CAGE Code	57HH3	ENDOCHOICE, INC. ENDO CHOICE PATHOLOGY
S.A.M. Registration	57HH3 [14154279]	ENDOCHOICE, INC. ENDO CHOICE PATHOLOGY
SEC	0001423167	ENDOCHOICE, INC. of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092915990	Shanghai ,China (Mainland) -> Savannah, Georgia	DISPOSABLE BRUSHCINCH PAD	518 CTN
2020092915992	Shanghai ,China (Mainland) -> Savannah, Georgia	SINGLE -USE GRASPING FORCEPS	24 CTN
2020092915991	Shanghai ,China (Mainland) -> Savannah, Georgia	LUBRICATING GEL	350 CTN
2020091126861	Shanghai ,China (Mainland) -> Savannah, Georgia	CINCH PAD	1040 CTN
2020091125713	Shanghai ,China (Mainland) -> Savannah, Georgia	IRRIGATION TUBING BITE BLOCK	492 CTN
2020091125687	Shanghai ,China (Mainland) -> Savannah, Georgia	FILTER/BITE BLOCK	440 CTN
2020091125586	Shanghai ,China (Mainland) -> Savannah, Georgia	CINCH PAD	1040 CTN
2020091125655	Shanghai ,China (Mainland) -> Savannah, Georgia	LUBRICATING GEL	700 CTN