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FDA 510(k)

Anchor Bolt (as an accessory to Depth Electrodes)

K-Number: K181544 · 2018-08-09

ApplicantAd-Tech Medical Instrument Corporation
Decision Date2018-08-09
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Anchor Bolt (as an accessory to Depth Electrodes) is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2018-08-09 under 510(k) number K181544. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anchor Bolt (as an accessory to Depth Electrodes)?

Anchor Bolt (as an accessory to Depth Electrodes) is a medical device that received FDA 510(k) clearance on 2018-08-09. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K181544.

When did Anchor Bolt (as an accessory to Depth Electrodes) receive FDA 510(k) clearance?

Anchor Bolt (as an accessory to Depth Electrodes) received FDA 510(k) clearance on 2018-08-09, under 510(k) number K181544.

Who is the listed applicant for Anchor Bolt (as an accessory to Depth Electrodes)?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anchor Bolt (as an accessory to Depth Electrodes)?

The FDA product code for Anchor Bolt (as an accessory to Depth Electrodes) is GZL.

Other records listing Ad-Tech Medical Instrument Corporation 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.

K223276Anchor Bolts as Accessories to Depth ElectrodesK223269Spencer Probe Depth ElectrodesK191186Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural ElectrodeK170442Cranial Drill Bits and AccessoriesK163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth ElectrodesK152769FREMAP ELECTRODE

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Related Devices (Code: GZL)

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.

K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd.K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); DeptBeijing Sinovation Medical Technology Co., Ltd.K250601Neuro Omega System; NeuroSmart SystemAlpha Omega Engineering , Ltd.K223276Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument CorporationK223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument CorporationK213170SENSOSEEG Depth ElectrodesSensomedical Labs, 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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