AVENTIX MEDICAL INC

Matched from indexed company URL: Aventix Medical Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
		AVENTIX MEDICAL INC	5	N	2026-01-01	23282 Mill Creek Dr Ste 350 Laguna Hills CA US 92653

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
350327	1023186011	K260255	AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)	GEI	2026-03-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GEI	1	2026-03-27

GUDID#

NOVOCLEAR™ Device - The NOVOCLEAR™ Device is a single-use, radiofrequency-based, hand-held device for use with the AVENTIX® PFX System to deliver pulsed field energy to tissue. The NOVOCLEAR™ Device consists of a handle, a dome-like electrode tip, and an electrical connector for connection to the AVENTIX® Generator.

Aventix Medical Inc.

2026-06-09

AVENTIX® PFX System - The AVENTIX® PFX System includes a generator, controller, and footswitch. The generator sets waveform parameters for the system, and the controller manages arming and disarming and provides system status information. The footswitch enables selective activation of pulsed field energy delivery via the connected NOVOCLEAR™ Device (sold separately).

Aventix Medical Inc.

2026-06-09