FDA 510(k)

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)

N.º K: K260397 · 2026-04-06

Fecha de decisión2026-04-06

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) is the device name listed in this FDA 510(k) record. The listed applicant is Hironic Co., Ltd.. It received FDA 510(k) clearance on 2026-04-06 under 510(k) number K260397. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)?

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Hironic Co., Ltd.. The 510(k) number is K260397.

When did SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) receive FDA 510(k) clearance?

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) received FDA 510(k) clearance on 2026-04-06, under 510(k) number K260397.

Who is the listed applicant for SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)?

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

What is the FDA product code for SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)?

The FDA product code for SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) is GEI.

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Otros registros que enlistan a Hironic Co., Ltd. como solicitante

K260387SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)K251334NEW DOUBLO 2.0 K241099Plasonic (Plasonic)K233123SILKRO K210084SILKRO K201773PICOHI

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Fuente oficial

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