# K081990: Lubricano Sterile Gel

- Pathway: 510(k) (Traditional)
- Applicant: Farco Pharma GmbH
- Decided: Dec 5, 2008 after 144 days
- Product code: FHX (Jelly, Lubricating, For Transurethral Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) lubricating jelly for transurethral surgical instruments: named in the summary without a submission number

## Most influential descendants
- K083358: Lubricano-Ultrasound (2009), 1 descendant of its own
- K211691: Ultrast Gel (2021), 0 descendants of its own

## Indications for use
Sterile gel for human use, e.g. in medical procedures - to aid the introduction of catheters and endoscopic instruments in transurethral examinations, and in intermittent catheterization - particularly for incontinence treatment.

Source page: https://510kreport.com/device/K081990
Methodology: https://510kreport.com/methodology