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PROLONG

DEN130047 Class II Direct
Decision Date
2015-03-20
Sponsor / Applicant
Ergon Medical , Ltd.

Technical Specification

510(k) Submission ID DEN130047
Product Code PIA
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5025
Decision Date 2015-03-20
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

PROLONG received FDA 510(k) clearance under submission number DEN130047, sponsored by Ergon Medical , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2015-03-20.

Classification & Regulation

This clearance is catalogued under FDA product code PIA and 21 CFR 876.5025, within the Gastroenterology, Urology review panel as a Class II device.