Dilating Urethral Sound
FDA 510(k) K933957 · Cook Urological, Inc.
510(k) numberK933957
Submission
- Device name
- Dilating Urethral Sound
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- August 12, 1993
- Decision date
- November 17, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FAH – Dilator, Urethral, Mechanical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5520
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FAH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K902370 | Modified Prostatic Urethroplasty Balloon CatheterFAH · Traditional | Boston Scientific Corp | 08/17/1990SE |
| K902124 | Dowd CatheterFAH · Traditional | Boston Scientific Corp | 08/09/1990SE |
| K831384 | Coaxial Balloon Urethral DilatorFAH · Traditional | Thomas J. Fogarty, M.D. | 07/26/1983SE |
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Questions and answers
When was Dilating Urethral Sound cleared by the FDA?
Dilating Urethral Sound (K933957) received a 510(k) decision of Substantially Equivalent on November 17, 1993, 97 days after the submission was received.
What is the product code of K933957?
The FDA product code is FAH – Dilator, Urethral, Mechanical, a Class II (moderate risk) device regulated under 21 CFR 876.5520.