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FDA 510(k)

SPROTTE SPECIAL NRFit

K-Number: K160296 · 2016-10-27

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2016-10-27
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPROTTE SPECIAL NRFit 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 2016-10-27 under 510(k) number K160296. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPROTTE SPECIAL NRFit?

SPROTTE SPECIAL NRFit is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K160296.

When did SPROTTE SPECIAL NRFit receive FDA 510(k) clearance?

SPROTTE SPECIAL NRFit received FDA 510(k) clearance on 2016-10-27, under 510(k) number K160296.

Who is the listed applicant for SPROTTE SPECIAL NRFit?

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 SPECIAL NRFit?

The FDA product code for SPROTTE SPECIAL NRFit is BSP.

Other records listing PAJUNK GmbH Medizintechnologie as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243690SonoMSKK243682SonoPlex STIM; SonoPlex IIK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureK243525SonoTAP and SonoTAP IIK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyK241954SonoBlock; SonoBlock II

View all 21 devices →

Related Devices (Code: BSP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243690SonoMSKPAJUNK GmbH MedizintechnologieK243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH MedizintechnologieK243525SonoTAP and SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH MedizintechnologieK241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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