Peristeen Anal Irrigation System
FDA 510(k) K140310 · Coloplast A/S
510(k) numberK140310
Submission
- Device name
- Peristeen Anal Irrigation System
- Applicant
- Coloplast A/S
Minneapolis, MN, US - Received
- February 7, 2014
- Decision date
- September 3, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | C.R. Bard, Inc. | 07/10/2026SE |
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| K233591 | StylusKNT · Traditional | Degania Silicone , Ltd. | 05/31/2024SE |
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| K140523 | Re-Trace Ureteral Access Sheath, 12/14 Ch/Fr, Length 35 CM, Length 45 CMFED · Special | 07/24/2014SE |
Questions and answers
When was Peristeen Anal Irrigation System cleared by the FDA?
Peristeen Anal Irrigation System (K140310) received a 510(k) decision of Substantially Equivalent on September 3, 2015, 573 days after the submission was received.
What is the product code of K140310?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.