BOWEN SUTURE PASSER
FDA 510(k) clearance K863146 · decided 1986-09-05
Clearance details
- K-number
- K863146
- Device name
- BOWEN SUTURE PASSER
- Applicant
- Bowen & Company, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-15
- Decision date
- 1986-09-05
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- HXI
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rockville, MD, 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 |
|---|---|---|
| Y WIRE 2 (K140576) | Safewire, LLC | 2014-05-20 |
| BOWEN KNOT PASSER (K863148) | Bowen & Company, Inc. | 1986-09-05 |
Recalls involving this device
No recalls on record reference this clearance.