Anchor Bolt (as an accessory to Depth Electrodes)— 510(k) K181544
Substantially EquivalentAd-Tech Medical Instrument Corporation
FDA 510(k) clearance K181544 for Anchor Bolt (as an accessory to Depth Electrodes), Substantially Equivalent on 2018-08-09. Applicant: Ad-Tech Medical Instrument Corporation. Device class: 2.
Clearance details
- Applicant
- Ad-Tech Medical Instrument Corporation
- Product code
- Code GZL
- Device class
- Class 2
- Regulation
- 21 CFR 882.1330
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oak Creek, WI, US
Recent devices under product code GZL
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view all- K191186 — Subdural 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 Electrode
- K170442 — Cranial Drill Bits and Accessories
- K163355 — Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
- K152769 — FREMAP ELECTRODE
- K152547 — DNAP Electrode
Recalls naming K181544
K-number listed on FDA's recall record- Z-2204-2019 — LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor bolt body with anchor bolt cap containing a green gasket and silicone cap, 26mm non-anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap - Product Usage: The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.
- Z-2408-2019 — Skull Anchor Bolts
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181544.
Data sourced from openFDA. This site is unofficial and independent of the FDA.