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)
Top companies in LTI
| Company | 510(k)s | Recalls |
|---|---|---|
| Ethicon Endo-Surgery Inc | 0 | 19 |
| Allergan | 0 | 2 |
| Apollo Endosurgery Inc | 0 | 2 |
| Reshape Medical Inc | 0 | 2 |
| Obalon Therapeutics Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2019 | Obalon 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 |
LTI | None listed |
| Nov 22, 2017 | Apollo 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 |
LTI | None listed |
| Nov 10, 2016 | Reshape 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 |
LTI | None listed |
| May 4, 2016 | Reshape 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 |
LTI | None listed |
| Sep 30, 2014 | Apollo 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 |
LTI | None listed |
| Nov 5, 2013 | Ethicon 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 |
LTI | None listed |
| Nov 5, 2013 | Ethicon 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 |
LTI | None listed |
| Nov 5, 2013 | Ethicon 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 |
LTI | None listed |
| May 2, 2011 | Allergan 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 |
LTI | None listed |
| Nov 18, 2010 | Allergan 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 |
LTI | None listed |
| Nov 2, 2010 | Ethicon 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 |
LTI | None listed |
| Nov 2, 2010 | Ethicon 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 |
LTI | None listed |
| Nov 2, 2010 | Ethicon 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 |
LTI | None listed |
| Nov 2, 2010 | Ethicon 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 |
LTI | None listed |
| Nov 2, 2010 | Ethicon 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 |
LTI | None listed |
| Nov 2, 2010 | Ethicon 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 |
LTI | None listed |
| Nov 2, 2010 | Ethicon 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 |
LTI | None listed |
| Nov 2, 2010 | Ethicon 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 |
LTI | None listed |
| Nov 2, 2010 | Ethicon 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 |
LTI | None listed |
| Nov 2, 2010 | Ethicon 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 |
LTI | None listed |
| Nov 2, 2010 | Ethicon Endo-Surgery Inc REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector, Calibration Tube and 15mm XCEL" trocar Product Code RLZB22DGT, Lot #: G4RK0E Terminated |
LTI | None listed |
| Nov 2, 2010 | Ethicon 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 |
LTI | None listed |
| Nov 2, 2010 | Ethicon Endo-Surgery Inc REALIZE Adjustable Gastric Band Pak with Endoscopic Dissector and 15mm XCEL" trocar Product Code RLZB22DT, Lot #: G4RK31, G4RR27, G4T28C Terminated |
LTI | None listed |
| Nov 2, 2010 | Ethicon 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 |
LTI | None listed |
| Nov 2, 2010 | Ethicon Endo-Surgery Inc REALIZE Adjustable Gastric Band Pak with 15mm XCEL" trocar Product Code RLZB22T, Lot #: G4RE82 Terminated |
LTI | None listed |
| Nov 2, 2010 | Ethicon 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 |
LTI | None listed |
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