FDA 510(k)

Intermittent Catheter (Not Finalized)

Número K: K211436 · 2022-01-27

Data da decisão2022-01-27

Código do produtoGBM

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Intermittent Catheter (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 2022-01-27 under 510(k) number K211436. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Intermittent Catheter (Not Finalized)?

Intermittent Catheter (Not Finalized) is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Hollister Incorporated. The 510(k) number is K211436.

When did Intermittent Catheter (Not Finalized) receive FDA 510(k) clearance?

Intermittent Catheter (Not Finalized) received FDA 510(k) clearance on 2022-01-27, under 510(k) number K211436.

Who is the listed applicant for Intermittent Catheter (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 Intermittent Catheter (Not Finalized)?

The FDA product code for Intermittent Catheter (Not Finalized) is GBM.

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Outros registros que listam Hollister Incorporated como candidato(a)

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 K213575Female IC (Not Finalized)K193148VaPro Plus Pocket, VaPro Plus

Ver todos os 11 dispositivos →

Dispositivos Relacionados (Código: GBM)

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited K200820SpeediCath Compact SetColoplast K192904SpeediCath Compact SetColoplast K200142SpeediCath SoftColoplast K200134Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd.

Fonte oficial

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