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FDA 510(k)

GETTIG UNIVERSAL VIAL ACCESS PIN

K-Number: K041232 · 2004-07-22

ApplicantGettig Pharmaceutical Instrument Co.
Decision Date2004-07-22
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GETTIG UNIVERSAL VIAL ACCESS PIN is the device name listed in this FDA 510(k) record. The listed applicant is Gettig Pharmaceutical Instrument Co.. It received FDA 510(k) clearance on 2004-07-22 under 510(k) number K041232. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GETTIG UNIVERSAL VIAL ACCESS PIN?

GETTIG UNIVERSAL VIAL ACCESS PIN is a medical device that received FDA 510(k) clearance on 2004-07-22. The listed applicant is Gettig Pharmaceutical Instrument Co.. The 510(k) number is K041232.

When did GETTIG UNIVERSAL VIAL ACCESS PIN receive FDA 510(k) clearance?

GETTIG UNIVERSAL VIAL ACCESS PIN received FDA 510(k) clearance on 2004-07-22, under 510(k) number K041232.

Who is the listed applicant for GETTIG UNIVERSAL VIAL ACCESS PIN?

The FDA 510(k) record lists Gettig Pharmaceutical Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GETTIG UNIVERSAL VIAL ACCESS PIN?

The FDA product code for GETTIG UNIVERSAL VIAL ACCESS PIN is LHI.

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 Gettig Pharmaceutical Instrument Co. 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.

K033409AMERSHAM HEALTH NEEDLE-GUARDK022495GETTIG DISPOSABLE SYRINGESK000455GETTIG GUARDK972285GETTIG STYRL-JECT DELIVERY SYSTEM

Related Devices (Code: LHI)

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.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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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