Clip Gun with Raney Type Scalp Clips
510(k) K896723
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK896723 | Date23 Mar 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HBO
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4150
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Clip, Scalp (FDA Product Code: HBO) designed for securing scalp tissue during neurosurgical procedures. It features a Raney type scalp clip, a mechanical attachment system that applies controlled pressure to stabilize the scalp, facilitating access and precision during cranial surgeries. The clips are intended to minimize movement and maintain a clear operative field while reducing the need for manual retraction.
The Clip Gun with Raney Type Scalp Clips is a single-use, non-sterile device supplied as a reusable hand-held applicator paired with disposable clips. It is classified as Class II under FDA regulations (21 CFR 882.4150) and holds a 510(k) clearance (K896723) for substantial equivalence in neurology applications. Storage requires protection from contamination and moisture; the applicator should be cleaned and disinfected between uses, while clips are intended for one-time surgical application. No MRI safety information is specified in the regulatory data.
Questions
AI-generated answers, 1 Oct 2026
What is the Clip Gun with Raney Type Scalp Clips used for?
This device is designed specifically for neurosurgical procedures to secure scalp tissue. The Raney type clips apply controlled pressure to stabilize the scalp, reducing movement and providing a clear operative field. This helps surgeons access the cranial area with precision while minimizing the need for manual retraction.
Is the Clip Gun reusable, and how are the clips supplied?
The Clip Gun itself is a reusable, hand-held applicator intended for multiple surgical uses. It is paired with disposable, single-use Raney type scalp clips. The reusable applicator must be cleaned and disinfected between uses, while the clips are intended for one-time surgical application only.
What storage requirements apply to the Clip Gun and clips?
The reusable Clip Gun must be stored in a clean, dry environment to prevent contamination and ensure proper functionality. The single-use clips should be stored in a sterile barrier until use, protected from moisture and environmental contamination. Follow manufacturer guidelines for optimal storage conditions.
Are the clips sterile, and how should they be handled?
The scalp clips are supplied as non-sterile and intended for single-use in surgical settings. They should be opened and handled using sterile techniques to maintain a sterile field during neurosurgical procedures. Sterilization is not applicable to the clips, as they are designed for one-time use.
What regulatory clearance does the Clip Gun with Raney Type Scalp Clips hold?
This device holds a 510(k) clearance (K896723) from the FDA, demonstrating substantial equivalence in neurology applications. It is classified as a Class II medical device under 21 CFR 882.4150, indicating it has undergone regulatory review for safety and effectiveness in its intended use.