CAL · Laryngoscope, Non-Rigid
Anesthesiology · 21 CFR 868.5530 · Class 1
Overview
| Product Code | CAL |
|---|---|
| Device Name | Laryngoscope, Non-Rigid |
| Regulation | 21 CFR 868.5530 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K951195 | FI-10P | Pentax Precision Instrument Corp. | Apr 6, 1995 | SESE |
| K951194 | FI-10M | Pentax Precision Instrument Corp. | Apr 6, 1995 | SESE |
| K872895 | HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. | Haemonetics Corp. | Jan 11, 1988 | SESE |
| K852994 | REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 | Reichert-Jung, Inc. | Jul 29, 1985 | SESE |
| K850978 | OLYMPUS LF-1 INTUBATION SCOPE | Olympus Corp. | May 23, 1985 | SESE |
| K802331 | AO FLEXIBLE LARYNGOSCOPE, #LS-7 | American Optical Corp. | Oct 10, 1980 | SESE |
| K801364 | AO STYLET LARYNGOSCOPE MODEL SLS | American Optical Corp. | Jun 17, 1980 | SESE |
| K791634 | AO STYLET LARYNGOSCOPE, MODEL SLS-1 | American Optical Corp. | Sep 17, 1979 | SESE |
Top Applicants
- American Optical Corp. — 3 clearances
- Pentax Precision Instrument Corp. — 2 clearances
- Reichert-Jung, Inc. — 1 clearance
- Olympus Corp. — 1 clearance
- Haemonetics Corp. — 1 clearance
