FDA 510(k) Premarket Notification K120857: EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX

Submission Details & Decision

Normalized public record details for 510(k) notification K120857.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K120857

Applicant / Sponsor

Ncontact Surgical, Inc.

Device Name

EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX

Product Code

OCL

Decision Date

2012-11-13

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General, Plastic Surgery (SU)

Clearance Type

Traditional

Third Party Flag

Date Received

2012-03-21

Related Establishments / Registrations

Sterigenics U.S., LLC Registration: 1036836 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
Covidien Registration: 1717344 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
CEA Medical Manufacturing, Inc. Registration: 1721983 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
ARMM, INC. Registration: 2028523 View Registration
REKO DENTAL, LLC Registration: 2087259 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
MINNETRONIX, INC. Registration: 2133810 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 2134265 View Registration
VESTA Registration: 2182291 View Registration
MEDTRONIC PERFUSION SYSTEMS Registration: 2184009 View Registration
LYNX Medical Pennsylvania Registration: 2528981 View Registration
APICAL INSTRUMENTS Registration: 2954783 View Registration
Medtronic Grand Rapids Registration: 3003955307 View Registration
MIDWEST STERILIZATION CORP. Registration: 3005012805 View Registration
Varian Medical Systems, Inc Registration: 3008262715 View Registration
Medtronic, Inc. (Minneapolis, MN 55447) Registration: 3008592544 View Registration
MEDIPLAST ISRAEL LTD Registration: 3008729892 View Registration
Synergy Health AST, LLC Registration: 3009882464 View Registration
ATRICURE, INC. Registration: 3011706110 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
Covidien Registration: 3026612481 View Registration
NAS MED LLC FZ Registration: 3035387162 View Registration
IGEA SPA Registration: 9611854 View Registration
MANUFACTURERA DENTAL CONTINENTAL Registration: 9616065 View Registration
GALIL MEDICAL LTD. Registration: 9616793 View Registration

Public Record Disclaimer

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.