PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER— 510(k) K112860

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K112860 for PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER, Substantially Equivalent on 2012-06-08. Applicant: Coloplast A/S.

Clearance details

Applicant: Coloplast A/S
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2011-09-30
Decision date: 2012-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.