# K083189: Steri-Lub Lubrication Gel

- Pathway: 510(k) (Special)
- Applicant: Avail Medical Products, Inc.
- Decided: Nov 21, 2008 after 23 days
- Product code: KMJ (Lubricant, Patient)
- Device class: 1
- Regulation: 21 CFR 880.6375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944969 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944969: Steri-Lub Lubrication Gel, Horizon Medical, Inc. (1995) Summary page 1.

## Indications for use
The Steri-Lub Lubricating Gel is intended to be used in procedures requiring a sterile product (surgical and urological). The Lubrication Gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

Source page: https://510kreport.com/device/K083189
Methodology: https://510kreport.com/methodology