FDA 510(k) Premarket Notification K103263: ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY

Submission Details & Decision

Normalized public record details for 510(k) notification K103263.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K103263

Applicant / Sponsor

Covidien, Formerly US Surgical A Divison of Tyco H

Device Name

ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY

Product Code

GDW

Decision Date

2010-11-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General, Plastic Surgery (SU)

Clearance Type

Special

Third Party Flag

Date Received

2010-11-04

Related Establishments / Registrations

C.R. BARD, INC. Registration: 1018233 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
GYRUS ACMI, INC. Registration: 1037007 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
Atalys Registration: 1047423 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
ANDERSEN SCIENTIFIC, INC. Registration: 1064858 View Registration
DAVOL INC., SUB. C.R. BARD, INC. Registration: 1213643 View Registration
COOPERSURGICAL, INC. Registration: 1216677 View Registration
LACEY MANUFACTURING COMPANY LLC Registration: 1218017 View Registration
SMITH & NEPHEW INC. Registration: 1219602 View Registration
Covidien Registration: 1219930 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
Primo Medical Group, INC Registration: 1222928 View Registration
Sequel Special Products d.b.a Nissha Medical Technologies Registration: 1287329 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
Isomedix Operations, Inc. Registration: 1450662 View Registration
ETHICON ENDO-SURGERY, INC. Registration: 1527736 View Registration
NORWOOD MEDICAL LLC Registration: 1531174 View Registration
ISOMEDIX OPERATIONS INC Registration: 1643817 View Registration
Steritec Services, LLC Registration: 1647149 View Registration
Isomedix Operations Inc. Registration: 1650907 View Registration
Sterigenics U.S., LLC Registration: 1721686 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
SURGICAL INSTRUMENT MANUFACTURERS, LLC Registration: 1935627 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
BARD PERIPHERAL VASCULAR, INC. Registration: 2020394 View Registration
Sterigenics U.S., LLC Registration: 2022435 View Registration
SURGIN SURGICAL INSTRUMENTATION, INC. Registration: 2023739 View Registration
PARTER MEDICAL PRODUCTS, INC. Registration: 2024311 View Registration
ARMM, INC. Registration: 2028523 View Registration
Sterigenics U.S., LLC Registration: 2029015 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
Isomedix Operations, Inc Registration: 2032098 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
CARBON MEDICAL TECHNOLOGIES, INC. Registration: 2134494 View Registration
ORTHOFIX US LLC Registration: 2183449 View Registration
ENGINEERED PLASTIC COMPONENTS, INC. Registration: 2183469 View Registration
ETHICON, INC. Registration: 2210968 View Registration
Viant Medical, Inc Registration: 2244012 View Registration
LYNX Medical NJ Registration: 2244478 View Registration
Covidien Registration: 2647580 View Registration
STERIS ISOMEDIX PUERTO RICO, INC. Registration: 2648623 View Registration
Sterigenics U.S. LLC Registration: 2953359 View Registration
INTUITIVE SURGICAL, INC. Registration: 2955842 View Registration
INTUITIVE SURGICAL, INC. Registration: 3001675293 View Registration
SMITH & NEPHEW INC. Registration: 3003604053 View Registration
OBERG MEDICAL PRODUCTS COMPANY Registration: 3003639920 View Registration
FOREFRONT MEDICAL TECHNOLOGY (PTE) LTD. Registration: 3003700453 View Registration
GYRUS ACMI, INC. Registration: 3003790304 View Registration
CADEX ELECTRONICS, INC. Registration: 3003800159 View Registration
Teleflex Medical de Tecate, S. de R.L de C.V. Registration: 3003898360 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
USGI MEDICAL Registration: 3004447686 View Registration
TOOLS FOR SURGERY, LLC Registration: 3004550973 View Registration
CATCHER TECHNOLOGY CO., LTD. Registration: 3004812220 View Registration
ETHICON ENDO-SURGERY, LLC Registration: 3005075853 View Registration
BARD SHANNON LIMITED Registration: 3005636544 View Registration
C.R. BARD, INC. Registration: 3006082230 View Registration
Covidien Medical Products (Shanghai) Manufacturing LLC Registration: 3006451981 View Registration
ETHICON, INC. Registration: 3006638824 View Registration
Hangzhou Fushan Medical Appliance Co., Ltd. Registration: 3006787036 View Registration
Sterigenics Shanghai ETO Ltd. Registration: 3007007790 View Registration
Intuitive Surgical, S. de R.L. de C.V. Registration: 3007084728 View Registration
ANIKA THERAPEUTICS, INC. Registration: 3007093114 View Registration
SAMAX PRECISION INC. Registration: 3007111496 View Registration
Hayden Medical Inc Registration: 3007137643 View Registration
MERIL ENDO SURGERY PVT. LTD. Registration: 3007205024 View Registration
TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD. Registration: 3007222388 View Registration
Paragon Medical - Mansfield, Bridgemedica Registration: 3007544634 View Registration
ETHICON, LLC Registration: 3007791599 View Registration
Sinolinks Medical Innovation, Inc. Registration: 3008383115 View Registration
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO.,LTD Registration: 3008388437 View Registration
VERIDIAM, INC Registration: 3009161688 View Registration
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LISI MEDICAL REmmele Registration: 3009941480 View Registration
Teleflex LLC (NADC) Registration: 3010041511 View Registration
BIOTRONIX HEALTHCARE INDUSTRIES INC. Registration: 3010131137 View Registration
Medtronic (Shanghai) Medical Technology Co., Ltd. Registration: 3010326740 View Registration
BOLDER SURGICAL, LLC Registration: 3010377594 View Registration
Sterigenics Costa Rica S.R.L. Registration: 3010432890 View Registration
REACH SURGICAL, INC. Registration: 3010913847 View Registration
Gyrus ACMI, Inc. Registration: 3011050570 View Registration
FENGH MEDICAL CO., LTD. Registration: 3011052945 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
Opus KSD, Inc. Registration: 3011301103 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
MEDAS, INC. Registration: 3012050423 View Registration
VICTOR MEDICAL INSTRUMENTS CO., LTD Registration: 3012428834 View Registration
Teleflex Medical Inc. Registration: 3012481535 View Registration
Tessy Plastics Corp. Registration: 3012806810 View Registration
LEXINGTON MEDICAL, INC. Registration: 3012998149 View Registration
SHARP FLUIDICS, INC. Registration: 3013002341 View Registration
ORTA MEDICAL LTD Registration: 3013188547 View Registration
Intuitive Surgical G.K. Registration: 3013283620 View Registration
INTUITIVE SURGICAL, INC. Registration: 3013942591 View Registration
EZISURG MEDICAL CO., LTD. Registration: 3014264910 View Registration
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration
COOPER MEDICAL, SRL Registration: 3014295858 View Registration
Mass Precision, Inc. Registration: 3014309390 View Registration
BURAK GLOBAL IC VE DIS TIC LTD STI Registration: 3014461810 View Registration
SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI Registration: 3014479313 View Registration
MICONVEY TECHNOLOGIES CO., LTD. Registration: 3014932737 View Registration
Nypro Healthcare Baja Inc. (Albuquerque) Registration: 3015183635 View Registration
Nypro Healthcare Baja Inc. (Torres) Registration: 3015185328 View Registration
SUPREME SCREW PRODUCTS Registration: 3015336263 View Registration
CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI Registration: 3015453963 View Registration
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Schneider ASR B.V. Registration: 3016678045 View Registration
ETHICON, INC. Registration: 3017102971 View Registration
BRDH Registration: 3017196117 View Registration
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AKSHAR GAMMA STERILES LLP Registration: 3018052045 View Registration
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Intuitive Surgical, Inc. Registration: 3018126215 View Registration
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Intuitive Surgical, Inc. Registration: 3022626486 View Registration
MDTGLOBAL, A.S. Registration: 3024021261 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
NAS MED LLC FZ Registration: 3035387162 View Registration
Sterigenics EO Canada, Inc. Registration: 9611665 View Registration
Covidien Registration: 9612501 View Registration
Sterigenics S. de R.L. de C.V. Registration: 9616517 View Registration
Coastline de Mexico SA de CV Registration: 9681572 View Registration
ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II Registration: 9710649 View Registration

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