Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LOWER BOWEL EVACUATION SYSTEM

K-Number: K941279 · 1995-10-12

ApplicantTiller Mind Body, Inc.
Decision Date1995-10-12
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LOWER BOWEL EVACUATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tiller Mind Body, Inc.. It received FDA 510(k) clearance on 1995-10-12 under 510(k) number K941279. The device is classified under product code KPL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOWER BOWEL EVACUATION SYSTEM?

LOWER BOWEL EVACUATION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-12. The listed applicant is Tiller Mind Body, Inc.. The 510(k) number is K941279.

When did LOWER BOWEL EVACUATION SYSTEM receive FDA 510(k) clearance?

LOWER BOWEL EVACUATION SYSTEM received FDA 510(k) clearance on 1995-10-12, under 510(k) number K941279.

Who is the listed applicant for LOWER BOWEL EVACUATION SYSTEM?

The FDA 510(k) record lists Tiller Mind Body, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOWER BOWEL EVACUATION SYSTEM?

The FDA product code for LOWER BOWEL EVACUATION SYSTEM is KPL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tiller Mind Body, Inc. as applicant

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.

K071057COLONIC & ENEMA NOZZLEK962259LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)

Related Devices (Code: KPL)

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.

K201861Bio Fluff SystemGnali Bocia S.R.L.K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic PlusK152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10Colonplus Equipments & Speculums, S.L.K094022THE WATER LILYClearwater Products, LLCK071057COLONIC & ENEMA NOZZLETiller Mind Body, Inc.K051344COLONIC AND ENEMA NOZZLEUltimate Concepts, Inc.

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.

↑