ClearanceBrief
Product code LTI ยท Class 3

Implant, Intragastric For Morbid Obesity

0510(k)s in 12 months (0 all time)
0recalls in 12 months (26 all time)
0recalls that name a 510(k)
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Top companies in LTI

Company510(k)sRecalls
Ethicon Endo-Surgery Inc019
Allergan02
Apollo Endosurgery Inc02
Reshape Medical Inc02
Obalon Therapeutics Inc01
DateFirm and productCodeLinked 510(k)
May 23, 2019Obalon Therapeutics Inc
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and beha
Completed
LTINone listed
Nov 22, 2017Apollo Endosurgery Inc
Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the band
Terminated
LTINone listed
Nov 10, 2016Reshape Medical Inc
ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conju
Terminated
LTINone listed
May 4, 2016Reshape Medical Inc
ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with die
Terminated
LTINone listed
Sep 30, 2014Apollo Endosurgery Inc
LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for we
Terminated
LTINone listed
Nov 5, 2013Ethicon Endo-Surgery Inc
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
Terminated
LTINone listed
Nov 5, 2013Ethicon Endo-Surgery Inc
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
Terminated
LTINone listed
Nov 5, 2013Ethicon Endo-Surgery Inc
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgic
Terminated
LTINone listed
May 2, 2011Allergan
Lap-Band Access Port Needle 10-Pack, 20 G x 51 mm (2 in.), Product Code: 8-20302-10, Lot Number: 9L01N 20 gauge, 51 mm (2 in.) length non-coring deflected tip (Huber) needle, used with the LAP-BAND Sy
Terminated
LTINone listed
Nov 18, 2010Allergan
LAP-BAND Adjustable Gastric Band System; Product codes: B-2105 (ACCSS PRT II KIT (0-10CC) US), B-2106 (ACCESS PRT II KIT (0-14CC) US), B-2210 (LP-BND SYS, 9.75, STER, US), B-2215 (LAP-BAND 9.75 W/ACC
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
Velocity" Injection Port and Applier Product Code PT2XV, Lot #: 1110603, 10060505, 11160512, 02090601, 03220609, 03220610, 06270601, 07170601, 09210601, 09270601, 20003156, ZHKBBB, ZJFBDK, ZJFBF6, ZJJ
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
SAGB VC Swedish Adjustable Gastric Band including Velocity" Injection Port Applier Product Code BD3XV, Lot #: 20008640, 20008641, 20008642, 20019968, 20019969, 20019975, 20019976, 20020378, 20024091,
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
SAGB QuickClose Swedish Adjustable Gastric Band including Velocity" Injection Port and Applier. Product Code BD2XV, Lot #: 1040602, , 1040603, , 10270503, , 11020504, , 11030502, , 11090510, , 1109051
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
REALIZE Injection Port and Applier. Product Code RLZPT2, Lot #: ZHLBCG, ZHPBB8, ZJBBBD, ZJBBBY, ZJCBB0, ZJCBBH, ZJCBDR, ZJJBMT, ZJKBCY, ZJMBPB, ZJNBB4, ZJNBBJ, ZJPBB5, ZKBBCJ, ZKBBGP, ZKBBLM, ZKCBDZ,
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
REALIZE Adjustable Gastric Band-C with Endoscopic Dissector. Product Code RLZB32D1, Lot #: G4RK0M, G4RL9X, G4RM94, G4RN9G, G4RY2M, G4RY3E, G4RY56, G4T00G, G4T137, G4T15H, G4T202, G4T224, G4T26M, G4T27
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector, Calibration Tube and 15mm XCEL" trocar. Product Code RLZB32DGT, Lot #: G4RE81, G4RK6N, G4RL6Z, G4T824, G4T98X, G4TN3R, G4TP1A & G4TR4J.
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and calibration tube. Product Code RLZB32DG1, Lot #: G4RK2R, G4RN94, G4RW06, G4RY5C, G4T160, G4T26C, G4T31A, G4T402, G4T46F, G4T695, G4T
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
REALIZE Adjustable Gastric Band-C Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code RLZB32DT, Lot #: G4RL1U, G4RL9A, G4RM2V, G4RM5T, G4RN6P, G4RP1M, G4RR5G, G4RW0R & G4TR72.
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
REALIZE Adjustable Gastric Band-C Pak with 15mm XCEL" trocar Product Code RLZB32T, Lot #: G4RK3F, G4RK51, G4RM62, G4RR1P, G4RW4H, G4RZ07, G4T01F, G4T290, G4T299, G4T525 & G4T821.
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
REALIZE Adjustable Gastric Band-C Product Code RLZB32, Lot #: ZJMBP7, ZJMBP8, ZJMBP9, ZJMBRB, ZJNBB6, ZJNBB7, ZJNBB8, ZJNBB9, ZJNBF5, ZJNBGM, ZJNBGN, ZJNBGP, ZJNBGR, ZJNBK4, ZJNBK5, ZJNBNH, ZJPBF3, ZK
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector, Calibration Tube and 15mm XCEL" trocar Product Code RLZB22DGT, Lot #: G4RK0E
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and Calibration Tube Product Code RLZB22DG1, Lot #: G4RJ98, G4T42A, G4T88X, G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code RLZB22DT, Lot #: G4RK31, G4RR27, G4T28C
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector Product Code RLZB22D1, Lot #: G4RJ90, G4RY0P, G4T15T, G4T289, G4T49Z, G4T52H, G4T861, G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TH28, G4TK
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
REALIZE Adjustable Gastric Band Pak with 15mm XCEL" trocar Product Code RLZB22T, Lot #: G4RE82
Terminated
LTINone listed
Nov 2, 2010Ethicon Endo-Surgery Inc
REALIZE Adjustable Gastric Band, Injection Port and Applier Product Code: RLZB22, RLZB22D, RLZB22DG Lot # ZHLBBB, ZHLBBC, ZHLBBD, ZHLBBF, ZHLBBG, ZHLBCM, ZHNBC3, ZHPBBV, ZHPBBY, ZJBBB1, ZJBBB2, ZJBBB3
Terminated
LTINone listed

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