Medsurg Seldinger Needle
510(k) K854294
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854294 | Date13 Jan 1986 | 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- Withdrawn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
- DRC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1390
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Medsurg Seldinger Needle is a trocar, a sharp-pointed surgical instrument designed for piercing tissue or vascular structures to facilitate the insertion of a cannula. It is specifically engineered for use in cardiovascular procedures, enabling access for catheterization or other interventional techniques by creating a pathway through the skin or vessel wall. The device is classified under product code DRC and adheres to Class II regulatory standards, requiring special controls to ensure safety and performance.
This single-use device is intended for sterile use in controlled clinical settings, such as operating rooms or catheterization labs. It is supplied pre-sterilized and packaged for one-time application to minimize infection risk. The Medsurg Seldinger Needle has received FDA 510(k) clearance under the Cardiovascular Device Advisory Committee, with a decision date of January 13, 1986. No additional regulatory markings (e.g., MRI safety, reusable status) are specified in the available data.
Other devices from Medsurg Industries, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Medsurg Seldinger Needle used for?
The Medsurg Seldinger Needle is a trocar designed specifically for piercing tissue or vascular structures to create a pathway for catheter insertion. It is primarily used in cardiovascular procedures to facilitate access for catheterization or other interventional techniques, such as inserting a cannula through the skin or vessel wall.
How is the Medsurg Seldinger Needle supplied and prepared for use?
The Medsurg Seldinger Needle is supplied pre-sterilized and packaged for single-use only. This packaging ensures minimal risk of contamination and infection, making it ideal for sterile clinical settings like operating rooms or catheterization labs. The device is not intended for reuse.
Is the Medsurg Seldinger Needle reusable or single-use?
The Medsurg Seldinger Needle is explicitly designed as a single-use device. Its pre-sterilized packaging and intended use in controlled clinical environments emphasize infection control, making reuse unsafe and contraindicated.
What regulatory pathway does the Medsurg Seldinger Needle follow?
The Medsurg Seldinger Needle has received FDA 510(k) clearance under the Cardiovascular Device Advisory Committee. It falls under product code DRC and adheres to Class II regulatory standards, requiring special controls to ensure safety and performance. The clearance decision date is January 13, 1986.
What clinical settings is the Medsurg Seldinger Needle intended for?
This device is intended for use in controlled clinical settings where sterility is critical, such as operating rooms or catheterization labs. Its single-use design and pre-sterilized packaging align with infection prevention protocols in these environments.