Apollo Endosurgery Inc

FDA Filings

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

USANASDAQAPENDUNS 782960954

Apollo Endosurgery Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3011609021
FEI Number3011609021
NameDavid Hooper PhD
Owner & OperatorApollo Endosurgery, Inc.
Contact Address1120 S Capital of TX Hwy Bldg 1, Ste 300
Austin TX 78746 US
Official Correspondent
  • David M Hooper, PhD
  • x-512-2795157-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1120 S Capital of TX Hwy Bldg 1, Ste 300
Austin, TX 78746 US
Establishment Type
  • Repack or Relabel Medical Device
  • Sterilize Medical Device for Another Party (Contract Sterilizer)
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3006722112
FEI Number3006722112
NameAPOLLO ENDOSURGERY INC
Owner & OperatorApollo Endosurgery, Inc.
Contact Address1120 S Capital of TX Hwy Bldg 1, Ste 300
Austin TX 78746 US
Official Correspondent
  • David M Hooper, PhD
  • x-512-2795157-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1120 S Capital of TX Hwy Bldg 1, Ste 300
Austin, TX 78746 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Apollo Endosurgery, Inc.
LAP-BAND B-204012021-12-30
Apollo Endosurgery, Inc.
LAP-BAND B-20172021-12-30
Apollo Endosurgery, Inc.
LAP-BAND C-23652021-12-30
Apollo Endosurgery, Inc.
LAP-BAND C-23602021-12-30
Apollo Endosurgery, Inc.
RapidPort EZ C-23062021-12-30
Apollo Endosurgery, Inc.
RapidPort EZ C-23042021-12-30
Apollo Endosurgery, Inc.
Access Port RapidPort EZ Kit B-23062021-12-30
Apollo Endosurgery, Inc.
LAP-BAND System Access Port I Kit B-21072021-12-30
Apollo Endosurgery, Inc.
RapidPort EZ Tubing Kit A-203312021-12-30
Apollo Endosurgery, Inc.
RapidPort EZ C-203902021-12-30
APOLLO ENDOSURGERY INC
ORBERA® Intragastric Balloon (IGB) System2021-12-21
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon (IGB) System2021-08-12
Apollo Endosurgery, Inc.
X-Tack Endoscopic HeliX Tacking System XTACK-235-H2021-07-20
Apollo Endosurgery, Inc.
X-Tack Endoscopic HeliX Tacking System XTACK-160-H2021-07-20
Apollo Endosurgery, Inc.
X-Tack Endoscopic HeliX Tacking System CNH-C01-213-L2021-07-20
Apollo Endosurgery, Inc.
OverStitch Endoscopic Suturing System Sx ESS-G02-Sx12021-06-03
Apollo Endosurgery, Inc.
OverStitch Endoscopic Suturing System THX-165-0282021-03-17
Apollo Endosurgery, Inc.
OverStitch Endoscopic Suturing System CNH-G01-0002021-03-17
Apollo Endosurgery, Inc.
OverStitch Endoscopic Suturing System ESS-G02-1602021-03-17
Apollo Endosurgery, Inc.
LAP-BAND B-203022021-01-08
Apollo Endosurgery, Inc.
LAP-BAND B-203012021-01-08
Apollo Endosurgery, Inc.
LAP-BAND System Adjustment Kit B-203102021-01-08
Apollo Endosurgery, Inc.
X-Tack Endoscopic HeliX Tacking System2020-12-15
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon System2020-10-16
Apollo Endosurgery, Inc.
OverStitch Endoscopic Suturing System PLY-G02-020-APL2019-11-08
David Hooper PhD [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System and Accessories2019-08-30
David Hooper PhD [Apollo Endosurgery, Inc.]
Apollo Endosurgery 2-0 Polypropylene Suture2019-08-30
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System and Accessories2019-08-30
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
Apollo Endosurgery 2-0 Polypropylene Suture2019-08-30
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon System2019-07-19
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon System2019-06-03
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
ReShape Integrated Dual Balloon System2019-02-15
APOLLO ENDOSURGERY INC
Orbera Intragastric Balloon2018-11-28
David Hooper PhD [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System2018-10-15
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System2018-10-15
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon System2018-09-04
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon2018-08-17
APOLLO ENDOSURGERY INC
Orbera Intragastric Balloon System2018-05-31
APOLLO ENDOSURGERY INC
Orbera Intragastric Balloon System2018-01-12
David Hooper PhD [Apollo Endosurgery, Inc.]
Overstitch Sx Endoscopic Suturing System2017-11-29
David Hooper PhD [Apollo Endosurgery, Inc.]
Overstitch Sx Endoscopic Suturing System Tissue Helix2017-11-29
David Hooper PhD [Apollo Endosurgery, Inc.]
Overstitch Endoscopic Suturing System Suture Cinch2017-11-29
David Hooper PhD [Apollo Endosurgery, Inc.]
OverStitch ESS Suture - polypropylene 2-02017-11-29
David Hooper PhD [Apollo Endosurgery, Inc.]
OverStitch ESS Suture - polydioxanone 2-02017-11-29
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
Overstitch Sx Endoscopic Suturing System2017-11-29
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
Overstitch Sx Endoscopic Suturing System Tissue Helix2017-11-29
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
Overstitch Endoscopic Suturing System Suture Cinch2017-11-29
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
OverStitch ESS Suture - polypropylene 2-02017-11-29
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
OverStitch ESS Suture - polydioxanone 2-02017-11-29
David Hooper PhD [Apollo Endosurgery, Inc.]
Overstitch Sx Endoscopic Suturing System2017-11-29
David Hooper PhD [Apollo Endosurgery, Inc.]
Overstitch Sx Endoscopic Suturing System Tissue Helix2017-11-29
David Hooper PhD [Apollo Endosurgery, Inc.]
Overstitch Endoscopic Suturing System Suture Cinch2017-11-29
David Hooper PhD [Apollo Endosurgery, Inc.]
OverStitch ESS Suture - polypropylene 2-02017-11-29
David Hooper PhD [Apollo Endosurgery, Inc.]
OverStitch ESS Suture - polydioxanone 2-02017-11-29
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
Overstitch Sx Endoscopic Suturing System2017-11-29
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
Overstitch Sx Endoscopic Suturing System Tissue Helix2017-11-29
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
Overstitch Endoscopic Suturing System Suture Cinch2017-11-29
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
OverStitch ESS Suture - polypropylene 2-02017-11-29
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
OverStitch ESS Suture - polydioxanone 2-02017-11-29
Apollo Endosurgery Inc
OverStitch SX Endoscopic Suturing System (ESS)2017-11-15
APOLLO ENDOSURGERY INC
Orbera Intragastric Balloon2017-08-21
APOLLO ENDOSURGERY INC
Orbera Intragastric Balloon System2017-06-06
APOLLO ENDOSURGERY INC
ORBERA Intragastric Balloon System2017-05-01
APOLLO ENDOSURGERY INC
ORBERA INTRAGASTRIC BALLOON SYSTEM2016-05-23
APOLLO ENDOSURGERY INC
ORBERA INTRAGASTRIC BALLOON SYSTEM2016-03-02
APOLLO ENDOSURGERY INC
ORBERA INTRAGASTRIC BALLOON SYSTEM2016-02-26
David Hooper PhD [Apollo Endosurgery, Inc.]
Gastric Balloon Suction Catheter2015-09-21
David Hooper PhD [Apollo Endosurgery, Inc.]
ORBERA Intragastric Balloon2015-08-06
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
ORBERA Intragastric Balloon2015-08-06
APOLLO ENDOSURGERY INC
ORBERA INTRAGASTRIC BALLOON2015-08-05
David Hooper PhD [Apollo Endosurgery, Inc.]
Access Port Needle2014-09-12
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
Access Port Needle2014-09-12
David Hooper PhD [Apollo Endosurgery, Inc.]
RapidPort EZ Tubing Kit2013-12-19
David Hooper PhD [Apollo Endosurgery, Inc.]
RapidPort EZ Port Applier2013-12-19
David Hooper PhD [Apollo Endosurgery, Inc.]
RapidPort EZ Access Port Kit for LAP-BAND AP System Standard2013-12-19
David Hooper PhD [Apollo Endosurgery, Inc.]
RapidPort EZ Access Port Kit for LAP-BAND AP System Large2013-12-19
David Hooper PhD [Apollo Endosurgery, Inc.]
LAP-BAND System2013-12-19
David Hooper PhD [Apollo Endosurgery, Inc.]
LAP-BAND System Tubing Kit2013-12-19
David Hooper PhD [Apollo Endosurgery, Inc.]
LAP-BAND System Calibration Tube2013-12-19
David Hooper PhD [Apollo Endosurgery, Inc.]
LAP-BAND System Adjustment Kit2013-12-19
David Hooper PhD [Apollo Endosurgery, Inc.]
LAP-BAND System Access Port II Kit2013-12-19
David Hooper PhD [Apollo Endosurgery, Inc.]
LAP-BAND System Access Port I Kit2013-12-19
David Hooper PhD [Apollo Endosurgery, Inc.]
LAP-BAND AP System Standard with RapidPort EZ Access Port2013-12-19
David Hooper PhD [Apollo Endosurgery, Inc.]
LAP-BAND AP System Large with RapidPort EZ Access Port2013-12-19
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
OverTube Endoscopic Access System2012-12-05
APOLLO ENDOSURGERY, INC.
OVERTUBE ENDOSCOPIC ACCESS SYSTEM2012-09-28
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
SuMO Access and Tissue Resection System2011-11-28
APOLLO ENDOSURGERY, INC.
SUMO ACCESS AND TISSUE RESECTION SYSTEM2011-10-28
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
Gastric Port2011-03-16
APOLLO ENDOSURGERY, INC.
GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-002010-06-14
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
Endoscopic Scissors2009-09-08
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
Electrocautery Dilation Balloon2009-09-08
David Hooper PhD [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System2009-09-08
David Hooper PhD [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System Tissue Helix2009-09-08
David Hooper PhD [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System Suture Cinch2009-09-08
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System2009-09-08
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System Tissue Helix2009-09-08
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System Suture Cinch2009-09-08
David Hooper PhD [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System2009-09-08
David Hooper PhD [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System Tissue Helix2009-09-08
David Hooper PhD [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System Suture Cinch2009-09-08
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System2009-09-08
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System Tissue Helix2009-09-08
APOLLO ENDOSURGERY INC [Apollo Endosurgery, Inc.]
OverStitch Endoscopic Suturing System Suture Cinch2009-09-08
APOLLO ENDOSURGERY, INC.
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-1652009-06-26
APOLLO ENDOSURGERY, INC.
ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-002008-12-19
APOLLO ENDOSURGERY, INC.
OVERSTITCH ENDOSCOPIC SUTURE SYSTEM2008-08-18

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