Casandra Syringe Cap
510(k) K871443
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871443 | Date18 Aug 1987 | 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- Withdrawn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
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Casandra Syringe Cap is a syringe, piston medical device designed to secure and protect the plunger of a syringe. It is classified under FDA regulation 880.5860 and intended for use in general hospital settings. This cap ensures a sterile barrier between the syringe contents and external contaminants, maintaining aseptic conditions during storage or transport.
The device is supplied as a single-use component, intended for attachment to standard syringe barrels. It is not intended for reuse and must be discarded after use to prevent cross-contamination. No specific MRI safety information is provided, and the cap is not sterilized by the manufacturer—sterilization must be performed by the healthcare facility prior to use. Authorized under FDA 510(k) clearance (K871443), it adheres to traditional review standards and is classified as a Class II device.
Questions
AI-generated answers, 1 Oct 2026
What is the Casandra Syringe Cap designed to protect?
The Casandra Syringe Cap is specifically designed to secure and protect the plunger of a syringe. It creates a sterile barrier between the syringe contents and external contaminants, ensuring aseptic conditions during storage or transport. This prevents potential contamination of the syringe’s contents, which is critical in maintaining patient safety and sterility in clinical environments.
Is the Casandra Syringe Cap intended for reuse?
No, the Casandra Syringe Cap is intended for single-use only. It is not designed to be reused after attachment to a syringe. Reusing the cap could lead to cross-contamination and compromise the sterility of subsequent syringe uses, posing risks to patients and healthcare workers.
Does the manufacturer provide sterilization for the Casandra Syringe Cap?
No, the manufacturer does not sterilize the Casandra Syringe Cap. Sterilization must be performed by the healthcare facility prior to use. This ensures that the cap meets the specific sterilization protocols and standards required by the facility, reducing the risk of introducing contaminants during clinical procedures.
What type of syringes is the Casandra Syringe Cap compatible with?
The Casandra Syringe Cap is designed for attachment to standard syringe barrels. While it is not explicitly limited to specific syringe sizes or types, its primary function is to fit securely over the plunger of conventional syringes used in general hospital settings. Compatibility should be verified by the facility based on their specific syringe models in use.
Are there any special storage instructions for the Casandra Syringe Cap?
The Casandra Syringe Cap should be stored in a clean, dry environment to prevent exposure to contaminants before use. Since it is not pre-sterilized by the manufacturer, it is essential to follow the healthcare facility’s sterilization protocols before attaching it to a syringe. Proper storage ensures the cap remains free from dust, moisture, or other potential sources of contamination.