Codman RF-12 Disposable Scalp Clip Applier

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K894778 ↗

FDA Product Code

HBO

Device Class

Class II

Regulation

21 CFR Part 882.4150

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Codman & Shurtleff, Inc. →

• What is the Codman RF-12 Disposable Scalp Clip Applier used for?

  The Codman RF-12 Disposable Scalp Clip Applier is designed specifically for neurosurgical procedures to secure scalp incisions. It applies disposable scalp clips to maintain wound closure, helping to minimize postoperative complications such as dehiscence or infection. This is particularly important in sterile surgical environments where infection control is critical.

• Is the Codman RF-12 Disposable Scalp Clip Applier reusable or single-use?

  The Codman RF-12 Disposable Scalp Clip Applier is intended for single-use only. This design ensures sterility and reduces the risk of cross-contamination in surgical settings. After application, the device must be discarded to comply with infection control protocols.

• How is the Codman RF-12 Disposable Scalp Clip Applier supplied?

  The Codman RF-12 Disposable Scalp Clip Applier is supplied sterile, ready for immediate use in neurosurgical procedures. The sterile packaging must be maintained until the device is applied, ensuring optimal conditions for wound closure.

• What regulatory classification does the Codman RF-12 Disposable Scalp Clip Applier hold?

  The Codman RF-12 Disposable Scalp Clip Applier is classified as a Class II medical device under FDA regulation 882.4150. It holds FDA clearance through a 510(k) submission (K894778) and is intended for use in neurosurgical settings as a scalp clip applier.

• Are there any special storage requirements for the Codman RF-12 Disposable Scalp Clip Applier?

  The Codman RF-12 Disposable Scalp Clip Applier must be stored according to the sterile packaging guidelines provided by the manufacturer. Proper storage ensures the device remains uncontaminated and ready for use in surgical environments, maintaining its integrity for single-use applications.