21 CFR 876.5160 — Clamp, Penile
Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5160
Identification
A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.
Classification Rationale
Class I (general controls). Except when intended for internal use, 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 |
|---|---|---|---|---|
| FHA | Clamp, Penile | 1 | 11 | |
| MNG | External Urethral Occluder, Urinary Incontinence-Control, Female | 1 | 7 |
