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FDA 510(k)

BIFURCATED VACCINATING NEEDLE

K-Number: K012515 · 2001-09-19

ApplicantPrecision Medical Products, Inc.
Decision Date2001-09-19
Product CodeSCL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIFURCATED VACCINATING NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Precision Medical Products, Inc.. It received FDA 510(k) clearance on 2001-09-19 under 510(k) number K012515. The device is classified under product code SCL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIFURCATED VACCINATING NEEDLE?

BIFURCATED VACCINATING NEEDLE is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Precision Medical Products, Inc.. The 510(k) number is K012515.

When did BIFURCATED VACCINATING NEEDLE receive FDA 510(k) clearance?

BIFURCATED VACCINATING NEEDLE received FDA 510(k) clearance on 2001-09-19, under 510(k) number K012515.

Who is the listed applicant for BIFURCATED VACCINATING NEEDLE?

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

What is the FDA product code for BIFURCATED VACCINATING NEEDLE?

The FDA product code for BIFURCATED VACCINATING NEEDLE is SCL.

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 Precision Medical Products, 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.

K031630BIFURCATED ALLERGY SKIN TESTING NEEDLE

Related Devices (Code: SCL)

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.

K250983Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)Asistan MedikalK222385Bifurcated NeedleAnhui Tiankang Medical Technology Co., Ltd.K182582Oryum and Ovem Epidermal Deri Prick Test ApplicatorAllergy & Applicator Depot, LLCK172062AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test TrayMedscience Science Research Group, Inc.K162917Allerhope Allergy Skin TesterProcare Industrial Co., LimitedK032528BD ECLIPSE BIFURCATED NEEDLEBecton, Dickinson & CO

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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