MICROSURGICAL WIRE LOOP
FDA 510(k) clearance K890221 · decided 1989-01-27
Clearance details
- K-number
- K890221
- Device name
- MICROSURGICAL WIRE LOOP
- Applicant
- Kinetic Medical Products
- Decision
- Substantially Equivalent
- Date received
- 1989-01-18
- Decision date
- 1989-01-27
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- JYQ
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Erie, PA, 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 |
|---|---|---|
| EAR LOOP (K870761) | Treace Medical, Inc. | 1987-03-03 |
Recalls involving this device
No recalls on record reference this clearance.