Softline Spring Clip
FDA 510(k) K000098 · Novare Surgical Systems, Inc.
510(k) numberK000098
Submission
- Device name
- Softline Spring Clip
- Applicant
- Novare Surgical Systems, Inc.
Cupertino, CA, US - Received
- January 13, 2000
- Decision date
- April 12, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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| 510(k) | Device | Decision |
|---|---|---|
| K072715 | Realhand High Dexterity InstrumentsGCJ · Special | 10/16/2007SE |
| K071488 | Realhand High Dexterity (HD) InstrumentsGCJ · Special | 06/29/2007SE |
| K043541 | Endolink True Movement SystemGCJ · Traditional | 03/10/2005SE |
| K032589 | Enclose II Anastomosis Assist DeviceDXC · Special | 09/05/2003SE |
| K023682 | Enclose Anastomosis Assist DeviceDXC · Traditional | 01/16/2003SE |
| K010727 | Flexline ClampDXC · Traditional | 08/09/2002SE |
| K010694 | Includer ClampDXC · Traditional | 02/11/2002SE |
| K992980 | Engage Jaw InsertsDXC · Traditional | 06/08/2000SE |
Questions and answers
When was Softline Spring Clip cleared by the FDA?
Softline Spring Clip (K000098) received a 510(k) decision of Substantially Equivalent on April 12, 2000, 90 days after the submission was received.
What is the product code of K000098?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.