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FDA 510(k)

BALLPEN SPINAL NEEDLE W/WO INTRODUCER

K-Number: K011122 · 2001-11-16

ApplicantRusch Intl.
Decision Date2001-11-16
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BALLPEN SPINAL NEEDLE W/WO INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Rusch Intl.. It received FDA 510(k) clearance on 2001-11-16 under 510(k) number K011122. 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 BALLPEN SPINAL NEEDLE W/WO INTRODUCER?

BALLPEN SPINAL NEEDLE W/WO INTRODUCER is a medical device that received FDA 510(k) clearance on 2001-11-16. The listed applicant is Rusch Intl.. The 510(k) number is K011122.

When did BALLPEN SPINAL NEEDLE W/WO INTRODUCER receive FDA 510(k) clearance?

BALLPEN SPINAL NEEDLE W/WO INTRODUCER received FDA 510(k) clearance on 2001-11-16, under 510(k) number K011122.

Who is the listed applicant for BALLPEN SPINAL NEEDLE W/WO INTRODUCER?

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

What is the FDA product code for BALLPEN SPINAL NEEDLE W/WO INTRODUCER?

The FDA product code for BALLPEN SPINAL NEEDLE W/WO INTRODUCER is BSP.

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Other records listing Rusch Intl. 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.

K033023INTERMITTENT URETHRAL CATHETERSK030559RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEMK023666RUSCH GUIDED CHOLANGIOGRAPHY CATHETERK023918RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESSK023964RUSCH MICROLARYNGEAL TUBEK021540RUSCH EDGAR TUBE

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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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