510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935548Substantially Equivalent

Cathejell S Sterile Lubricating Jelly

Pharmazeutische Fabrik Montavit GmbH, Wilton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935548 is the FDA 510(k) clearance record for CATHEJELL S STERILE LUBRICATING JELLY, a class II device, cleared for Pharmazeutische Fabrik Montavit GmbH on under FDA product code FHX (Jelly, Lubricating, For Transurethral Surgical Instrument). FDA records list one 510(k) clearance for Pharmazeutische Fabrik Montavit GmbH. As of , FDA records show no recalls naming K935548.

Clearance record

Decision date
Received
(133 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
Pharmazeutische Fabrik Montavit GmbH Cmr Associates, Wilton CT
510(k) summary
Statement
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