COALESCENT U-CLIP- AND ACCESSORIES
FDA 510(k) clearance K023125 · decided 2002-12-18
Clearance details
- K-number
- K023125
- Device name
- COALESCENT U-CLIP- AND ACCESSORIES
- Applicant
- Coalescent Surgical
- Decision
- Substantially Equivalent
- Date received
- 2002-09-19
- Decision date
- 2002-12-18
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NJU
- Device class
- 2
- Regulation number
- 878.4495
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NON-BIOABSORBABLE STAPLE (K023372) | Onux Medical, Inc. | 2002-12-27 |
Recalls involving this device
No recalls on record reference this clearance.