SILICONE TYMPANOSTOMY TUBES
FDA 510(k) clearance K932166 · decided 1993-07-26
Clearance details
- K-number
- K932166
- Device name
- SILICONE TYMPANOSTOMY TUBES
- Applicant
- Smith & Nephew Richards, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-04
- Decision date
- 1993-07-26
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- ETD
- Device class
- 2
- Regulation number
- 874.3880
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Bartlett, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Duravent Silicone Ventilation Tube. Model Number: 240075. recall (Z-0707-2025) | Olympus Corporation of the Americas | 2024-12-19 |
| Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle recall (Z-1004-2024) | Olympus Corporation of the Americas | 2024-02-07 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OSTEOPAL (P810020/S005) | Smith & Nephew Richards, Inc. | 1998-10-15 |
| PALACOS E-FLOW (OSTEOPAL) BONE CEMENT (P810020/S004) | Smith & Nephew Richards, Inc. | 1998-07-30 |
| PALACOS R BONE CEMENT (P810020/S003) | Smith & Nephew Richards, Inc. | 1992-02-14 |
| PALACOS R BONE CEMENT (P810020/S002) | Smith & Nephew Richards, Inc. | 1989-01-30 |
| PALACOS R BONE CEMENT (P810020/S001) | Smith & Nephew Richards, Inc. | 1984-08-14 |
| PALACOS R BONE CEMENT (P810020) | Smith & Nephew Richards, Inc. | 1984-02-02 |