Cleared Traditional

Lubricating Jelly

K142473 · Sion Biotext Medical , Ltd. · General Hospital
Apr 2015
Decision
222d
Days
Class 1
Risk

About This 510(k) Submission

K142473 is an FDA 510(k) clearance for the Lubricating Jelly, a Lubricant, Patient (Class I — General Controls, product code KMJ), submitted by Sion Biotext Medical , Ltd. (Upper Galilee, IL). The FDA issued a Cleared decision on April 13, 2015, 222 days after receiving the submission on September 3, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6375.

Submission Details

510(k) Number K142473 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2014
Decision Date April 13, 2015
Days to Decision 222 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KMJ — Lubricant, Patient
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6375