WAX CURETTE TIP
FDA 510(k) clearance K823916 · decided 1983-01-21
Clearance details
- K-number
- K823916
- Device name
- WAX CURETTE TIP
- Applicant
- Treace Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-28
- Decision date
- 1983-01-21
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- JYG
- 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 |
|---|---|---|
| EAR CURETTE (K932609) | Ear Tech, Inc. | 1993-07-21 |
| FLEX-LOOP FLEXIBLE EAR CORETTE (K852039) | Bionix Corp. | 1985-06-11 |
| CURETTE (K841354) | Treace Medical, Inc. | 1984-07-06 |
| EAR CURETTE, VARIOUS (K841001) | Premier Dental Products Co. | 1984-05-29 |
| ENT CURRETTES (K822273) | Kelleher Corp. | 1982-08-30 |
| OPERATIVE EAR CURRETTES & RELATED ITEM (K822006) | Kelleher Corp. | 1982-08-12 |
Recalls involving this device
No recalls on record reference this clearance.