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)

Pinpoint GT Needles

K-Number: K163216 · 2017-06-27

ApplicantC.R. Bard, Inc.
Decision Date2017-06-27
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Pinpoint GT Needles is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2017-06-27 under 510(k) number K163216. 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 Pinpoint GT Needles?

Pinpoint GT Needles is a medical device that received FDA 510(k) clearance on 2017-06-27. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K163216.

When did Pinpoint GT Needles receive FDA 510(k) clearance?

Pinpoint GT Needles received FDA 510(k) clearance on 2017-06-27, under 510(k) number K163216.

Who is the listed applicant for Pinpoint GT Needles?

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

What is the FDA product code for Pinpoint GT Needles?

The FDA product code for Pinpoint GT Needles 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.

NCT03911700Prophylactic Reinforcement of Ventral Abdominal Incisions TrialACTIVE_NOT_RECRUITINGNCT04634916Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF SystemRECRUITINGNCT05711316The BD Liverty™ TIPS Stent Graft StudyACTIVE_NOT_RECRUITINGNCT05945329Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant AugmentationRECRUITINGNCT07282860An Evaluation of the PureWick™ Male External Catheter Versus an Established Comparator Overnight in the Home Setting for Incontinence in Adult MalesCOMPLETEDNCT07744945Evaluation of Male and Female External Catheters for Urine Output Monitoring in the ICUNOT_YET_RECRUITING

Other records listing C.R. Bard, 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.

PMA P800002Agent, absorbable hemostatic, collagen basedK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)PMA P170042System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatmentK254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitK252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)K251864Rubber Utility Catheter

View all 74 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.

↑