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FDA 510(k)

COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM

K-Number: K083770 · 2009-11-23

ApplicantColoplast A/S
Decision Date2009-11-23
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2009-11-23 under 510(k) number K083770. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM?

COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-23. The listed applicant is Coloplast A/S. The 510(k) number is K083770.

When did COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM receive FDA 510(k) clearance?

COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM received FDA 510(k) clearance on 2009-11-23, under 510(k) number K083770.

Who is the listed applicant for COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM?

The FDA product code for COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM is KNT.

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Related Devices (Code: KNT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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