The Bioplate Battery Powered Drill
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K022986 FDA 510(k)
- FDA Product Code
- HBC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4360 FDA 510(k)
- Regulation Number
- 882.4360 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bioplate Battery Powered Drill is a handheld, battery-operated surgical instrument used to create pilot holes in cranial bone. It consists of a metal housing containing a motor, powered by four AAA batteries.
The device is supplied by Bioplate, Inc. and has received FDA 510(k) clearance under product code HBC and regulation number 882.4360. It is classified as a Class II device and is not intended for bone cutting or bone shaping indications.
Frequently asked questions
What is the Bioplate Battery Powered Drill used for?
The Bioplate Battery Powered Drill is a handheld, battery-operated surgical instrument used to create pilot holes in cranial bone during neurosurgical procedures. It is not intended for bone cutting or bone shaping, as specified in its FDA 510(k) clearance, and is designed solely for preparing precise entry points in the skull for subsequent surgical steps.
How is the Bioplate Battery Powered Drill powered and supplied?
The device is powered by four AAA batteries housed within its metal casing, making it fully portable and cordless for use in the operating room. It is supplied by Bioplate, Inc. as a ready-to-use instrument, with no external power source or charging system required, and is intended for immediate clinical use upon unpacking.
Is the Bioplate Battery Powered Drill reusable or single-use?
The Bioplate Battery Powered Drill is designed for multiple uses, as it is a durable, battery-powered surgical instrument with a metal housing and motor that can be cleaned and reused after appropriate sterilization procedures. It is not labeled as single-use, and its construction supports repeated clinical applications under standard hospital reprocessing protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: THE BIOPLATE BATTERY POWERED DRILL (K022986) — FDA 510 (k) | Innolitics, The Bioplate Battery Powered Drill 510 (k) FDA Premarket Notification ..., PDF Summary of Safety and Effectiveness KO22986, PDF K022986 - the Bioplate Battery Powered Drill
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K022986 | Class II | Active |
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Manufacturer
- Manufacturer
- Bioplate, Inc.
Sources (1)
- FDA 510(k) K022986 24 fields · synced Sep 22, 2026