CBG · Spreader, Cuff
Anesthesiology · 21 CFR 868.5760 · Class 1
Overview
| Product Code | CBG |
|---|---|
| Device Name | Spreader, Cuff |
| Regulation | 21 CFR 868.5760 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
| GMP Exempt | Yes |
Identification
A cuff spreader is a device used to install tracheal tube cuffs on tracheal or tracheostomy tubes.
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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K870600 | SOFT EAR STETHOSCOPE | Kalajian Ent. | Mar 19, 1987 | SESE |
Top Applicants
- Kalajian Ent. — 1 clearance
