RIGHT ANGLED PICK
FDA 510(k) clearance K841355 · decided 1984-07-03
Clearance details
- K-number
- K841355
- Device name
- RIGHT ANGLED PICK
- Applicant
- Treace Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-04-02
- Decision date
- 1984-07-03
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- JYT
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, 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 |
|---|---|---|
| MICROSURGICAL EAR PICKS (K822176) | Kelleher Corp. | 1982-08-16 |
Recalls involving this device
No recalls on record reference this clearance.