Cleared Traditional

K083770 - COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM

K083770 is an FDA 510(k) clearance for COLOPLAST PERISTEEN ANAL IRRIGATION (PA..., 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 340-day FDA review.

K083770 · Coloplast A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
340d
Days
Class 2
Risk

K083770 is an FDA 510(k) clearance for the COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Coloplast A/S (Minneapolis, US). The FDA issued a Cleared decision on November 23, 2009 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K083770

510(k) Number K083770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2008
Decision Date November 23, 2009
Days to Decision 340 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
209d slower than avg
Panel avg: 131d · This submission: 340d
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 K083770.
INSTAFLO BOWEL CATHETER SYSTEM KIT
K100273 · Hollister, Inc. · Apr 2010
IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT
K100173 · Sainath Intellectual Properties, LLC · Apr 2010
URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK
K093653 · Uresil, LLC · Feb 2010
ENTRACARE GASTROSTOMY FEEDING TUBE
K092418 · Entracare, LLC · Oct 2009
IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT
K092049 · Sainath Intellectual Properties, LLC · Oct 2009
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
K091637 · Corpak Medsystems · Sep 2009
K083770 · COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
Download PDF FDA Summary Coloplast A/S