OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT
FDA 510(k) clearance K981543 · decided 1998-06-08
Clearance details
- K-number
- K981543
- Device name
- OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT
- Applicant
- The Olympus Optical Co.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-30
- Decision date
- 1998-06-08
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP recall (Z-0557-2024) | Olympus Corporation of the Americas | 2023-12-14 |
| Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airwa recall (Z-0332-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| Tracheal fiberscope-airway management, which includes observation to access airway anatomy recall (Z-0338-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus an recall (Z-0344-2024) | Aizu Olympus Co., Ltd. | 2023-11-17 |
| Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP. recall (Z-2504-2023) | Olympus Corporation of the Americas | 2023-08-31 |