FDA 510(k)

SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture

Número K: K250774 · 2025-06-25

RequerentePAJUNK GmbH Medizintechnologie

Data da decisão2025-06-25

Código do produtoBSP

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture is the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2025-06-25 under 510(k) number K250774. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture?

SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K250774.

When did SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture receive FDA 510(k) clearance?

SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture received FDA 510(k) clearance on 2025-06-25, under 510(k) number K250774.

Who is the listed applicant for SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture?

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

What is the FDA product code for SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture?

The FDA product code for SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture is BSP.

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Outros registros que listam PAJUNK GmbH Medizintechnologie como candidato(a)

K243690SonoMSK K243682SonoPlex STIM; SonoPlex II K243525SonoTAP and SonoTAP II K241953SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology K241954SonoBlock; SonoBlock II K230701Stim2Go

Ver todos os 21 dispositivos →

Dispositivos Relacionados (Código: BSP)

K243690SonoMSKPAJUNK GmbH Medizintechnologie K243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH Medizintechnologie K243525SonoTAP and SonoTAP IIPAJUNK GmbH Medizintechnologie K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie K241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie K240253Reach NeedleAerin Medical, Inc.

Fonte oficial

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