T-TUBE INSERTER
FDA 510(k) clearance K870978 · decided 1987-03-19
Clearance details
- K-number
- K870978
- Device name
- T-TUBE INSERTER
- Applicant
- Sur-Med Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-10
- Decision date
- 1987-03-19
- Days to decision
- 9 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
- St. Louis, MO, 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 |
| ARMSTRONG V TUBE SUCTION INSERTER (K822349) | Treace Medical, Inc. | 1982-09-13 |
| TYTAN TUBE INSERTER (K822348) | Treace Medical, Inc. | 1982-09-07 |
Recalls involving this device
No recalls on record reference this clearance.