Silicone Rectal Balloon
FDA 510(k) K930135 · Cook Urological, Inc.
510(k) numberK930135
Submission
- Device name
- Silicone Rectal Balloon
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- January 12, 1993
- Decision date
- October 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FEN – Device, Cystometric, Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Silicone Rectal Balloon cleared by the FDA?
Silicone Rectal Balloon (K930135) received a 510(k) decision of Substantially Equivalent on October 8, 1993, 269 days after the submission was received.
What is the product code of K930135?
The FDA product code is FEN – Device, Cystometric, Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.1620.