Geister Retractor for Neuro- and Spine Surgery
by Geister Medizin Technik GmbH
510(k) K180610
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180610 | Date29 Aug 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GZT
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4800
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Retractor, Self-Retaining, For Neurosurgery (Product Code: GZT), designed to provide stable retraction during neurosurgical and spinal procedures. It is engineered to maintain precise geometry under load and ensure accuracy even after repeated sterilization cycles, supporting optimal surgical exposure and access.
The Geister Retractor is supplied as a reusable surgical instrument, intended for use in sterile operating environments. It is classified under FDA regulation 21 CFR 882.4800 and holds a 510(k) clearance (K180610) for neuro- and spine surgery applications. Manufactured in Tuttlingen, Germany, it adheres to international quality and safety standards, including ISO 13485 certification.
Other devices from Geister Medizin Technik GmbH
Questions
AI-generated answers, 1 Oct 2026
What is the Geister Retractor for neurosurgery and spine surgery used for?
The Geister Retractor for neurosurgery and spine surgery is a self-retaining retractor designed to provide stable and precise retraction during neurosurgical and spinal procedures. Its engineering ensures accurate geometry under load, which supports optimal surgical exposure and access, reducing the risk of tissue damage while improving visibility for the surgeon.
Is the Geister Retractor reusable or single-use?
The Geister Retractor is supplied as a reusable surgical instrument. It is engineered to maintain its performance and precision even after repeated sterilization cycles, making it suitable for multiple uses in sterile operating environments. This design ensures long-term reliability and cost-effectiveness for clinical settings.
What regulatory approvals does the Geister Retractor hold?
The Geister Retractor holds FDA 510(k) clearance (K180610) for use in neurosurgery and spine surgery applications. It is classified under FDA regulation 21 CFR 882.4800 and adheres to international quality and safety standards, including ISO 13485 certification. The device is manufactured in Tuttlingen, Germany, ensuring compliance with rigorous global regulatory requirements.
How is the Geister Retractor supplied, and what are its key features?
The Geister Retractor is supplied as a reusable instrument, intended exclusively for sterile operating environments. Its key features include stable retraction, precise geometry under load, and durability through repeated sterilization cycles. These attributes ensure consistent performance and reliability during neurosurgical and spinal procedures, enhancing surgical precision and patient outcomes.
What makes the Geister Retractor suitable for repeated use?
The Geister Retractor is designed with materials and construction that allow it to withstand repeated sterilization cycles without compromising its structural integrity or performance. This durability ensures that the retractor maintains its precise geometry and stability under load, providing consistent surgical exposure and access over multiple uses. Such design reliability is critical for high-volume clinical settings.