SHILEY LARYNGECTOMY TUBE
FDA 510(k) clearance K821993 · decided 1982-08-12
Clearance details
- K-number
- K821993
- Device name
- SHILEY LARYNGECTOMY TUBE
- Applicant
- Shiley, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-07-07
- Decision date
- 1982-08-12
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- KAC
- 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 |
|---|---|---|
| BARTON-MAYO TRACHEOSTOMA BUTTON (K901377) | Medical Innovations International, Inc. | 1990-06-14 |
| LARYNGECTOMY TUBE (K873992) | Portex, Inc. | 1988-03-24 |
| NORTHWESTERN VOICE RESTORATION KIT (K811428) | Universal Prosthetics, Inc. | 1981-06-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BJORK-SHILEY CARDIAC VALVE (P780008/S013) | Shiley, Inc. | 1986-10-31 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S014) | Shiley, Inc. | 1985-04-09 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S015) | Shiley, Inc. | 1984-11-26 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S011) | Shiley, Inc. | 1984-05-15 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S007) | Shiley, Inc. | 1983-05-20 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S005) | Shiley, Inc. | 1982-02-05 |