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APOLLO ENDOSURGERY INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30067221123006722112APOLLO ENDOSURGERY INC1Y2020-04-251120 S Capital of TX Hwy Bldg 1, Ste 300 Austin TX US 78746

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 GUDIDProductPhoneEmail
00811955020834OverStitch NXT Endoscopic Suturing System - Needle Driver and Anchor Exchange855-551-3123productcomplaints.us@apolloendo.com
00811955020896OverStitch NXT Endoscopic Suturing System - Needle Driver and Anchor Exchange855-551-3123productcomplaints.us@apolloendo.com
00811955020919NXT Tissue Helix Pro - Tissue Helix855-551-3123productcomplaints.us@apolloendo.com
00811955020933Apollo ESG NXT System - Single Channel Endobariatric System855-551-3123productcomplaints.us@apolloendo.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1079641012338125P140012RESHAPE INTEGRATED DUAL BALLOON SYSTEMLTI2015-07-28
1079641893474275P140008ORBERA INTRAGASTRIC BALLOONLTI2015-08-05
1079641916779720K191439OverStitch 2-0 Polypropylene SutureOCW2019-08-29
1079641551884497K181141OverStitch Endoscopic Suturing System and AccessoriesOCW2018-06-27
1079642059802659K171886OverStitch SX Endoscopic Suturing System (ESS)OCW2017-11-15
1079641367002273K122270OVERTUBE ENDOSCOPIC ACCESS SYSTEMFED2012-09-28
1079641905668621K103155SUMO ACCESS AND TISSUE RESECTION SYSTEMODC2011-10-28
1079641013053395K090583ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165KGE2009-06-26
1079641358138834K082114ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00KNS2008-12-19
1079641574428040K082102GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00FED2010-06-14
1079641118649435K081853OVERSTITCH ENDOSCOPIC SUTURE SYSTEMOCW2008-08-18
1079641372255758

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OCW42019-08-29
LTI22015-08-05
FED22012-09-28
ODC12011-10-28
KGE12009-06-26
KNS12008-12-19

PMA#

ORBERA ® Intragastric Balloon (IGB) System

2022-10-05

APOLLO ENDOSURGERY INC1120 S Capital Of Tx Hwybldg 1, Ste 300austin, TX 78746-0000 PMA NumberP140008 Supplement NumberS024 Date Received07/11/2022 Decision Date10/05/2022 Product Code LTI  Advisory Committee Gastroenterology/Urology Supplement Typereal-time...

PMN#

GUDID#

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