Peristeen Anal Irrigation System, Peristeen Anal Irrigation Accessory Unit, Peristeen Anal Irrigation Rectal Catheter
FDA 510(k) K112860 · Coloplast A/S
510(k) numberK112860
Submission
- Device name
- Peristeen Anal Irrigation System, Peristeen Anal Irrigation Accessory Unit, Peristeen Anal Irrigation Rectal Catheter
- Applicant
- Coloplast A/S
Plymouth, MN, US - Received
- September 30, 2011
- Decision date
- June 8, 2012
- 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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| K150935 | SpeediCath Compact EveGBM · Traditional | 07/02/2015SE |
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Questions and answers
When was Peristeen Anal Irrigation System, Peristeen Anal Irrigation Accessory Unit, Peristeen Anal Irrigation Rectal Catheter cleared by the FDA?
Peristeen Anal Irrigation System, Peristeen Anal Irrigation Accessory Unit, Peristeen Anal Irrigation Rectal Catheter (K112860) received a 510(k) decision of Substantially Equivalent on June 8, 2012, 252 days after the submission was received.
What is the product code of K112860?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.