TYTAN TUBE INSERTER
FDA 510(k) clearance K822348 · decided 1982-09-07
Clearance details
- K-number
- K822348
- Device name
- TYTAN TUBE INSERTER
- Applicant
- Treace Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-08-06
- Decision date
- 1982-09-07
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- JYM
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Walker, MI, 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 |
|---|---|---|
| DEANS DISPOSABLE T-TUBE INSERTER (K924901) | Exmoor Plastics , Ltd. | 1993-01-28 |
| T-TUBE INSERTER (K870978) | Sur-Med Instruments, Inc. | 1987-03-19 |
| ARMSTRONG V TUBE SUCTION INSERTER (K822349) | Treace Medical, Inc. | 1982-09-13 |
Recalls involving this device
No recalls on record reference this clearance.