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FDA 510(k)

STRYKER VENOM ELECTRODES AND CANNULAE

K-Number: K123178 · 2013-03-28

ApplicantStryker Instruments, Instruments Div.
Decision Date2013-03-28
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STRYKER VENOM ELECTRODES AND CANNULAE is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments, Instruments Div.. It received FDA 510(k) clearance on 2013-03-28 under 510(k) number K123178. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER VENOM ELECTRODES AND CANNULAE?

STRYKER VENOM ELECTRODES AND CANNULAE is a medical device that received FDA 510(k) clearance on 2013-03-28. The listed applicant is Stryker Instruments, Instruments Div.. The 510(k) number is K123178.

When did STRYKER VENOM ELECTRODES AND CANNULAE receive FDA 510(k) clearance?

STRYKER VENOM ELECTRODES AND CANNULAE received FDA 510(k) clearance on 2013-03-28, under 510(k) number K123178.

Who is the listed applicant for STRYKER VENOM ELECTRODES AND CANNULAE?

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

What is the FDA product code for STRYKER VENOM ELECTRODES AND CANNULAE?

The FDA product code for STRYKER VENOM ELECTRODES AND CANNULAE is GXI.

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Other records listing Stryker Instruments, Instruments Div. 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.

K113477IVAS 20MM (10 GAUGE) BALLOON CATHETERK093419IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVASK072702STRYKER ANTIMIC CATHETERK073017STRYKER STRI-SHIELD FLYTE TOGASK070078STRYKER T4 HYTREL TOGA

Related Devices (Code: GXI)

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.

K253907Disposable Radiofrequency CannulaABBOTT MEDICALK251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICALK250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker InstrumentsK241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.

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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