Lower Bowel Evacuation System

FDA 510(k) K941279 · Tiller Mind Body, Inc.

Substantially Equivalent

510(k) numberK941279

Submission

Device name
Lower Bowel Evacuation System
Applicant
Tiller Mind Body, Inc.
San Antonio, TX, US
Received
March 16, 1994
Decision date
October 12, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KPL – Colonic Irrigation System
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5220
Specialty
Gastroenterology, Urology

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More from Prime Pacific Health Innovations Corporation

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K071057Colonic & Enema NozzleKPL · Traditional 10/05/2007SE
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Questions and answers

When was Lower Bowel Evacuation System cleared by the FDA?

Lower Bowel Evacuation System (K941279) received a 510(k) decision of Substantially Equivalent on October 12, 1995, 575 days after the submission was received.

What is the product code of K941279?

The FDA product code is KPL – Colonic Irrigation System, a Class II (moderate risk) device regulated under 21 CFR 876.5220.