Steri-Cath MDI
510(k) K923559
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK923559 | Date25 Oct 1993 | 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- Withdrawn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
- CAF
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Steri-Cath MDI is a Nebulizer (Direct Patient Interface), designed for delivering aerosolized medications to patients via inhalation. It is intended for use in anesthesia applications, facilitating precise administration of gases or liquids to the respiratory tract. Constructed for sterile use, this device ensures minimal contamination risk during clinical procedures. Its design aligns with regulatory standards for Class II medical devices under the FDA’s classification system.
This device is supplied as a single-use item, adhering to sterile packaging to maintain integrity before clinical application. It is regulated under FDA 510(k) clearance (K923559) with a decision date of October 25, 1993, and falls under the product code CAF. The Steri-Cath MDI is intended for use in controlled environments such as operating rooms or anesthesia suites, where sterile and precise medication delivery is critical. No additional regulatory markings or MRI safety classifications are specified.