FDA 510(k)

Female IC (Not Finalized)

N.º K: K213575 · 2022-09-13

Fecha de decisión2022-09-13

Código de productoEZD

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Female IC (Not Finalized) is the device name listed in this FDA 510(k) record. The listed applicant is Hollister Incorporated. It received FDA 510(k) clearance on 2022-09-13 under 510(k) number K213575. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Female IC (Not Finalized)?

Female IC (Not Finalized) is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Hollister Incorporated. The 510(k) number is K213575.

When did Female IC (Not Finalized) receive FDA 510(k) clearance?

Female IC (Not Finalized) received FDA 510(k) clearance on 2022-09-13, under 510(k) number K213575.

Who is the listed applicant for Female IC (Not Finalized)?

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

What is the FDA product code for Female IC (Not Finalized)?

The FDA product code for Female IC (Not Finalized) is EZD.

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Otros registros que enlistan a Hollister Incorporated como solicitante

K253295Coude Sleeved IC; Coude Plus Sleeved IC K251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)K220667Sleeved IC K211436Intermittent Catheter (Not Finalized)K193148VaPro Plus Pocket, VaPro Plus

Ver todos los 11 dispositivos →

Dispositivos relacionados (Código: EZD)

K261418Liquick X-treme, Liquick X-treme PlusTeleflex Medical K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).Convatec K261658LoFric Origo Pro CoudéWellspect AB K262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.