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FDA 510(k)

SAFETY NEEDLE

K-Number: K051019 · 2005-07-25

ApplicantSarstedt, Inc.
Decision Date2005-07-25
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SAFETY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Sarstedt, Inc.. It received FDA 510(k) clearance on 2005-07-25 under 510(k) number K051019. 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 SAFETY NEEDLE?

SAFETY NEEDLE is a medical device that received FDA 510(k) clearance on 2005-07-25. The listed applicant is Sarstedt, Inc.. The 510(k) number is K051019.

When did SAFETY NEEDLE receive FDA 510(k) clearance?

SAFETY NEEDLE received FDA 510(k) clearance on 2005-07-25, under 510(k) number K051019.

Who is the listed applicant for SAFETY NEEDLE?

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

What is the FDA product code for SAFETY NEEDLE?

The FDA product code for SAFETY NEEDLE 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.

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Other records listing Sarstedt, 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.

K032150SAFETY-MULTIFLYK031359S-MONOVETTE EDTA K2-GELK024237URINE MONOVETTE BORIC ACIDK003382SARSTEDT NEEDLE PROTECTORK913622HEMOPLUS

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

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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