21 CFR 876.4590 — Sound, Metal, Interconnected
Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4590
Identification
An interlocking urethral sound is a device that consists of two metal sounds (elongated instruments for exploring or sounding body cavities) with interlocking ends, such as with male and female threads or a rounded point and mating socket, used in the repair of a ruptured urethra. The device may include a protective cap to fit over the metal threads.
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 § 876.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FBS | Sound, Metal, Interconnected | 1 | 1 |
