FBS · Sound, Metal, Interconnected
Gastroenterology, Urology · 21 CFR 876.4590 · Class 1
Overview
| Product Code | FBS |
|---|---|
| Device Name | Sound, Metal, Interconnected |
| Regulation | 21 CFR 876.4590 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K954972 | LYELL SOUND | Venture Management Corp. | Jan 24, 1996 | SESE |
Top Applicants
- Venture Management Corp. — 1 clearance
