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FDA 510(k)

TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC

K-Number: K080771 · 2008-11-10

ApplicantTop Corp.
Decision Date2008-11-10
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC is the device name listed in this FDA 510(k) record. The listed applicant is Top Corp.. It received FDA 510(k) clearance on 2008-11-10 under 510(k) number K080771. 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 TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC?

TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC is a medical device that received FDA 510(k) clearance on 2008-11-10. The listed applicant is Top Corp.. The 510(k) number is K080771.

When did TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC receive FDA 510(k) clearance?

TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC received FDA 510(k) clearance on 2008-11-10, under 510(k) number K080771.

Who is the listed applicant for TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC?

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

What is the FDA product code for TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC?

The FDA product code for TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC is GXI.

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Other records listing Top Corp. 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.

K062946TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TLK860449MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE

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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