Softline Spring Clip
by Novare Surgical Systems, Inc.
510(k) K000098
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000098 | Date12 Apr 2000 | 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- Withdrawn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
- DXC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4450
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The Softline Spring Clip is a vascular clamp, a medical device used in cardiovascular applications. It is classified as a class 2 device. The device is substantially equivalent to existing devices.
The Softline Spring Clip is supplied with FDA 510K authorization, with a product code of DXC. It was cleared on April 12, 2000, with the decision code SESE. The device is a spring clip, with the K number K000098.
Other devices from Novare Surgical Systems, Inc.
Questions
AI-generated answers, 28 Sep 2026
What is the Softline Spring Clip used for?
The Softline Spring Clip is used in cardiovascular applications as a vascular clamp.
Is the Softline Spring Clip supplied sterile?
The device data does not specify if the Softline Spring Clip is supplied sterile, it is recommended to check the packaging or manufacturer's instructions.
What is the regulatory status of the Softline Spring Clip?
The Softline Spring Clip has been cleared with FDA 510K authorization, with a product code of DXC and K number K000098.