Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal Catheter, System Strap, Irrigation Tube
FDA 510(k) K103254 · Coloplast A/S
510(k) numberK103254
Submission
- Device name
- Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal Catheter, System Strap, Irrigation Tube
- Applicant
- Coloplast A/S
Plymouth, MN, US - Received
- November 3, 2010
- Decision date
- January 31, 2011
- 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, Irrigation Accessory Unit, Irrigation Rectal Catheter, System Strap, Irrigation Tube cleared by the FDA?
Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal Catheter, System Strap, Irrigation Tube (K103254) received a 510(k) decision of Substantially Equivalent on January 31, 2011, 89 days after the submission was received.
What is the product code of K103254?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.