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FDA 510(k)

PRO-JECT(TM) SAFETY NEEDLE HOLDER

K-Number: K892665 · 1989-10-04

ApplicantPro-Tec Containers, Inc.
Decision Date1989-10-04
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRO-JECT(TM) SAFETY NEEDLE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Tec Containers, Inc.. It received FDA 510(k) clearance on 1989-10-04 under 510(k) number K892665. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-JECT(TM) SAFETY NEEDLE HOLDER?

PRO-JECT(TM) SAFETY NEEDLE HOLDER is a medical device that received FDA 510(k) clearance on 1989-10-04. The listed applicant is Pro-Tec Containers, Inc.. The 510(k) number is K892665.

When did PRO-JECT(TM) SAFETY NEEDLE HOLDER receive FDA 510(k) clearance?

PRO-JECT(TM) SAFETY NEEDLE HOLDER received FDA 510(k) clearance on 1989-10-04, under 510(k) number K892665.

Who is the listed applicant for PRO-JECT(TM) SAFETY NEEDLE HOLDER?

The FDA 510(k) record lists Pro-Tec Containers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO-JECT(TM) SAFETY NEEDLE HOLDER?

The FDA product code for PRO-JECT(TM) SAFETY NEEDLE HOLDER is JKA.

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 Pro-Tec Containers, 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.

K945273PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2K945274PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80K945275PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1K945276PRO-TEC DISPOSABLE SHARPS CONTAINERS 5GK942179PRO-TEC DISPOSABLE SHARPS CONTAINERS

Related Devices (Code: JKA)

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.

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

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.

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