14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE
FDA 510(k) clearance K122263 · decided 2012-09-28
Clearance details
- K-number
- K122263
- Device name
- 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE
- Applicant
- Symmetry Medical
- Decision
- Substantially Equivalent
- Date received
- 2012-07-27
- Decision date
- 2012-09-28
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- ODY
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Antioch, TN, 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 |
|---|---|---|
| TRANS-CATHETER EXTRACTOR (K063048) | Tran Pa-C, Inc. | 2007-09-14 |
Recalls involving this device
No recalls on record reference this clearance.