EAR KNIVES
FDA 510(k) clearance K840764 · decided 1984-05-21
Clearance details
- K-number
- K840764
- Device name
- EAR KNIVES
- Applicant
- Sharpoint, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-23
- Decision date
- 1984-05-21
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- JYO
- 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 |
|---|---|---|
| COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST (K910212) | Acoustic Imaging Technologies Corp. | 1991-07-11 |
| EAR KNIFE-VARIOUS (K841006) | Premier Dental Products Co. | 1984-05-30 |
| ROLLER KNIFE-TRANSVERSE -SAGITTAL (K833602) | Microtek Medical, Inc. | 1984-01-03 |
| KNIFE BLADE TIP (K823911) | Treace Medical, Inc. | 1983-01-21 |
| MYRINGOTOMY KNIFE (K772384) | Edward Weck, Inc. | 1978-01-17 |
| ROLLER KNIFE (K772372) | Edward Weck, Inc. | 1978-01-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SILK SURGICAL SUTURES (N85143/S004) | Sharpoint, Inc. | 1988-08-31 |
| SILK SURGICAL SUTURES (N85143/S007) | Sharpoint, Inc. | 1988-07-19 |
| SILK SURGICAL SUTURES (N85143/S006) | Sharpoint, Inc. | 1988-03-22 |
| SILK SURGICAL SUTURES (N85143/S005) | Sharpoint, Inc. | 1987-10-13 |
| SUTURES (N85143/S003) | Sharpoint, Inc. | 1987-08-27 |
| SUTURES (N85143/S002) | Sharpoint, Inc. | 1987-04-03 |
| SUTURES (N85143/S001) | Sharpoint, Inc. | 1986-10-27 |