Identifiers
- 510(k) Number
- K050628 FDA 510(k)
- FDA Product Code
- HBE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4310 FDA 510(k)
- Regulation Number
- 882.4310 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Anspach Coupler is a mechanical adapter classified as a drill, burr, trephine, and accessory (simple, powered). It functions as a coupling device designed to connect and transfer rotational speed and torque from a powered drill motor to a bone mill input spindle or similar surgical instrument.
This device is intended for use in neurosurgical procedures, where it attaches to the Anspach drill motor’s drive shaft to facilitate precise bone milling. Supplied as a reusable component, it is not sterile at shipment and must be sterilized prior to use. The coupler adheres to FDA 510(k) clearance (K050628) under regulation 882.4310, with no third-party involvement. No MRI safety or specific size variations are noted in the regulatory data.
Frequently asked questions
What is the Anspach Coupler used for in neurosurgery?
The Anspach Coupler is a mechanical adapter designed to connect a powered drill motor’s drive shaft to surgical instruments like bone mills. It transfers rotational speed and torque during neurosurgical procedures, enabling precise bone milling for craniotomies or other cranial surgeries.
Is the Anspach Coupler sterile when received?
No, the Anspach Coupler is not sterile at shipment. It is supplied as a reusable component and must be sterilized prior to use in any procedure to ensure patient safety and infection control.
How is the Anspach Coupler regulated and approved?
The Anspach Coupler holds FDA 510(k) clearance (K050628) under regulation 882.4310, classified as substantially equivalent to predicate devices. It was reviewed by the Neurology Advisory Committee and cleared through a traditional 510(k) process without third-party involvement.
Can the Anspach Coupler be used with MRI equipment?
The regulatory data for the Anspach Coupler does not specify MRI safety information. Clinicians should verify compatibility with their MRI systems and protocols before use to avoid interference or safety risks.
Are there different sizes or models of the Anspach Coupler?
The provided regulatory data does not mention specific size variations or multiple models for the Anspach Coupler. It is described as a single mechanical adapter designed for general neurosurgical use with powered drills.
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: K050628 FDA 510(k) - ANSPACH COUPLER | The Anspach Effort, Inc., ANSPACH COUPLER (K050628) — FDA 510 (k) | Innolitics, The Anspach Effort 2026 Company Profile: Valuation, Investors ..., PDF ANSPACH™ Power Tools EG1™ High Speed Electric System, Tom Anspach - Owner, The Anspach Effort Inc | LinkedIn
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050628 | Class II | Active |
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Manufacturer
- Manufacturer
- The Anspach Effort, Inc.
Sources (1)
- FDA 510(k) K050628 24 fields · synced Oct 1, 2026