FDA 510(k)

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)

K-Nummer: K160754 · 2016-09-09

Entscheidungsdatum2016-09-09

ProduktcodeGEI

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Venclose, Inc.. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K160754. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)?

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Venclose, Inc.. The 510(k) number is K160754.

When did Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) receive FDA 510(k) clearance?

Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) received FDA 510(k) clearance on 2016-09-09, under 510(k) number K160754.

Who is the listed applicant for Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)?

The FDA 510(k) record lists Venclose, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)?

The FDA product code for Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) is GEI.

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Weitere Einträge mit Venclose, Inc. als Antragsteller

K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)K250068Venclose digiRF Generator (VCRFG1)K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter

Verwandte Geräte (Code: GEI)

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Offizielle Quelle

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