510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081990Substantially Equivalent

Lubricano Sterile Gel

Farco Pharma GmbH, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081990 is the FDA 510(k) clearance record for LUBRICANO STERILE GEL, a class II device, cleared for Farco Pharma GmbH on under FDA product code FHX (Jelly, Lubricating, For Transurethral Surgical Instrument). FDA records list 2 510(k) clearances for Farco Pharma GmbH, from to . As of , FDA records show no recalls naming K081990.

Clearance record

Decision date
Received
(144 days to decision)
Product code
FHX Jelly, Lubricating, For Transurethral Surgical Instrument
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Farco Pharma GmbH 555 Eleventh St., NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FHX

Trailing 12 months

FDA records hold no clearances under product code FHX in the trailing twelve months.

FDA records show no clearances under product code FHX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FHX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260