Cleared Special

K083189 - STERI-LUB LUBRICATION GEL (FDA 510(k) Clearance)

Class I General Hospital device.

K083189 · Avail Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
23d
Days
Class 1
Risk

K083189 is an FDA 510(k) clearance for the STERI-LUB LUBRICATION GEL. Classified as Lubricant, Patient (product code KMJ), Class I - General Controls.

Submitted by Avail Medical Products, Inc. (Santa Ana, US). The FDA issued a Cleared decision on November 21, 2008 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6375 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Avail Medical Products, Inc. devices

Submission Details

510(k) Number K083189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2008
Decision Date November 21, 2008
Days to Decision 23 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 128d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KMJ Lubricant, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.