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FDA 510(k)

HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE

K-Number: K014073 · 2002-02-13

ApplicantPortex, Inc.
Decision Date2002-02-13
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Portex, Inc.. It received FDA 510(k) clearance on 2002-02-13 under 510(k) number K014073. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE?

HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE is a medical device that received FDA 510(k) clearance on 2002-02-13. The listed applicant is Portex, Inc.. The 510(k) number is K014073.

When did HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE receive FDA 510(k) clearance?

HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE received FDA 510(k) clearance on 2002-02-13, under 510(k) number K014073.

Who is the listed applicant for HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE?

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

What is the FDA product code for HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE?

The FDA product code for HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE is FMF.

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Other records listing Portex, 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.

K033080PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETERK031057PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KITK0237931ST RESPONSE INTERMEDIATE MANUAL RESUSCITATORK0141151ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XXK873992LARYNGECTOMY TUBEK874597THERMOVENT 600, 1200, T, 02

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Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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