Coalescent U-Clip- and Accessories
FDA 510(k) K023125 · Coalescent Surgical
510(k) numberK023125
Submission
- Device name
- Coalescent U-Clip- and Accessories
- Applicant
- Coalescent Surgical
Sunnyvale, CA, US - Received
- September 19, 2002
- Decision date
- December 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NJU – Suture, Nonabsorbable, Nitinol
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4495
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Soft tissue approximation.
Other 510(k)s with product code NJU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023372 | Non-Bioabsorbable StapleNJU · Traditional | Onux Medical, Inc. | 12/27/2002SE |
More from Onux Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K040821 | Coalescent Surgical U-Clip and AccessoriesFZP · Traditional | 04/23/2004SE |
| K031623 | Modification to Coalescent Surgical U-Clip and AccessoriesFZP · Special | 07/03/2003SE |
| K024366 | Coalescent Surgical U-Clip and AccessoriesFZP · Special | 01/17/2003SE |
| K021407 | Coalescent Surgical U-Clip - or Other TBD and AccessoriesFZP · Traditional | 07/03/2002SE |
| K013664 | Coalescent Surgical U-ClipNCA · Traditional | 01/24/2002SE |
| K012317 | Coalescent Surgical U-ClipFZP · Traditional | 08/31/2001SE |
| K003958 | Coalescent U-Clip Delivery and Disposal DeviceFZP · Traditional | 02/06/2001SE |
| K994160 | Coalescent Surgical Sutured-ClipFZP · Traditional | 02/04/2000SE |
Questions and answers
When was Coalescent U-Clip- and Accessories cleared by the FDA?
Coalescent U-Clip- and Accessories (K023125) received a 510(k) decision of Substantially Equivalent on December 18, 2002, 90 days after the submission was received.
What is the product code of K023125?
The FDA product code is NJU – Suture, Nonabsorbable, Nitinol, a Class II (moderate risk) device regulated under 21 CFR 878.4495.