21 CFR 868.5760 — Spreader, Cuff

Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5760

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.

Product Codes