FDA 510(k) Premarket Notification K082659: MODIFIED ENDO STICH

Submission Details & Decision

Normalized public record details for 510(k) notification K082659.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K082659

Applicant / Sponsor

Covidien Lp, Formerly Registered AS United States

Device Name

MODIFIED ENDO STICH

Product Code

OCW

Decision Date

2008-09-19

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Gastroenterology, Urology (GU)

Clearance Type

Special

Third Party Flag

Date Received

2008-09-12

Related Establishments / Registrations

Boston Scientific Corporation Registration: 1000121056 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
Sterigenics US LLC Registration: 1058584 View Registration
LACEY MANUFACTURING COMPANY LLC Registration: 1218017 View Registration
Covidien Registration: 1219930 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1319660 View Registration
MEDLINE INDUSTRIES, LP (Northpoint Services) Registration: 1422634 View Registration
ETHICON ENDO-SURGERY, INC. Registration: 1527736 View Registration
Isomedix Operations Inc. Registration: 1650907 View Registration
GRACE MANUFACTURING INC Registration: 1651252 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
KARL STORZ ENDOSCOPY-AMERICA, INC. Registration: 2020550 View Registration
ISOMEDIX OPERATIONS INC. Registration: 2245304 View Registration
Covidien Registration: 2647580 View Registration
STRYKER ENDOSCOPY Registration: 2936485 View Registration
Sterigenics U.S. LLC Registration: 2953359 View Registration
MEDI-LINE S.A. Registration: 3001169357 View Registration
Sterigenics US LLC Registration: 3002907620 View Registration
ETHICON ENDO-SURGERY, LLC Registration: 3005075853 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 3005099803 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
Boston Scientific Corporation Registration: 3007695959 View Registration
Medtronic Distribution Center Registration: 3009380063 View Registration
SUTURE EASE, INC. Registration: 3009956343 View Registration
Teleflex LLC (NADC) Registration: 3010041511 View Registration
Karl Storz Endoscopy-America, Inc. Registration: 3010202439 View Registration
STERISERVICES Registration: 3010383847 View Registration
Sterigenics Costa Rica S.R.L. Registration: 3010432890 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
Arthrocare Corporation Registration: 3012358417 View Registration
ORTA MEDICAL LTD Registration: 3013188547 View Registration
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration
SAGE PRODUCT DEVELOPMENT, INC. Registration: 3014328942 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
Nypro Healthcare Baja Inc. (Albuquerque) Registration: 3015183635 View Registration
Nypro Healthcare Baja Inc. (Torres) Registration: 3015185328 View Registration
BRDH Registration: 3017196117 View Registration
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration
STERIS Corporation de Republica Dominicana, S.R.L. Registration: 3017636737 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
IVUS ILAC SANAYI VE TICARET AS Registration: 3021632375 View Registration
ENDO TOOLS THERAPEUTICS S.A Registration: 3021721805 View Registration
TRANSLUMINAL Registration: 3022505496 View Registration
ENDOFIX MEDICAL TECHNOLOGIES Registration: 3031276312 View Registration
NAS MED LLC FZ Registration: 3035387162 View Registration
AESCULAP AG Registration: 9610612 View Registration
Covidien Registration: 9612501 View Registration
Assut Europe S.P.A. Registration: 9617547 View Registration
Boston Scientific Limited Registration: 9681260 View Registration
ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II Registration: 9710649 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.