Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPINAL TAP NEEDLE

K-Number: K910652 · 1991-07-24

ApplicantGesco Intl., Inc.
Decision Date1991-07-24
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPINAL TAP NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Gesco Intl., Inc.. It received FDA 510(k) clearance on 1991-07-24 under 510(k) number K910652. 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 SPINAL TAP NEEDLE?

SPINAL TAP NEEDLE is a medical device that received FDA 510(k) clearance on 1991-07-24. The listed applicant is Gesco Intl., Inc.. The 510(k) number is K910652.

When did SPINAL TAP NEEDLE receive FDA 510(k) clearance?

SPINAL TAP NEEDLE received FDA 510(k) clearance on 1991-07-24, under 510(k) number K910652.

Who is the listed applicant for SPINAL TAP NEEDLE?

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

What is the FDA product code for SPINAL TAP NEEDLE?

The FDA product code for SPINAL TAP NEEDLE is BSP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Gesco Intl., Inc. 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.

K954422PER-Q-CATH MID-LINEK940870UMBILI-CATHK940953UMBILI-CATH-SK940952UMBILI-CATH-S-DLK941672URI-CATH CATHETERK941232THORA-CATH

View all 26 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.

↑