Cleared Traditional

K112860 - PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER

K112860 is an FDA 510(k) clearance for PERISTEEN ANAL IRRIGATION SYSTEM, manufactured by Coloplast A/S. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K112860 · Coloplast A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
252d
Days
Class 2
Risk

K112860 is an FDA 510(k) clearance for the PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, P.... Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on June 8, 2012 after a review of 252 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K112860

510(k) Number K112860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date June 08, 2012
Days to Decision 252 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 131d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 532
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K112860.
TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)
K123659 · Actuated Medical, Inc. · Dec 2012
LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
K122030 · Degania Silicone , Ltd. · Sep 2012
TUBECLEAR
K121571 · Actuated Medical, Inc. · Jun 2012
DOBBHOFF DUAL PORT FEEDING TUBE
K112511 · Covidien Lp, Formerly Registered AS Kendall · May 2012
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
K112342 · Convatec, Inc. · Apr 2012
SAFETY SCREW CONNECTOR
K113719 · Abbott Laboratories · Apr 2012
K112860 · PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER
Download PDF FDA Summary Coloplast A/S