FDA 510(k)

DiscCath Needle Set

K-Number: K212328 · 2021-09-26

Decision Date2021-09-26

Product CodeBSP

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

DiscCath Needle Set is the device name listed in this FDA 510(k) record. The listed applicant is Disccath, LLC. It received FDA 510(k) clearance on 2021-09-26 under 510(k) number K212328. 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 DiscCath Needle Set?

DiscCath Needle Set is a medical device that received FDA 510(k) clearance on 2021-09-26. The listed applicant is Disccath, LLC. The 510(k) number is K212328.

When did DiscCath Needle Set receive FDA 510(k) clearance?

DiscCath Needle Set received FDA 510(k) clearance on 2021-09-26, under 510(k) number K212328.

Who is the listed applicant for DiscCath Needle Set?

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

What is the FDA product code for DiscCath Needle Set?

The FDA product code for DiscCath Needle Set is BSP.

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 Medizintechnologie K243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH Medizintechnologie K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH Medizintechnologie K243525SonoTAP and SonoTAP IIPAJUNK GmbH Medizintechnologie K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie K241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie

Official Source

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