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

Jelly, Lubricating, For Transurethral Surgical Instrument

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FHX is the FDA product code for Jelly, Lubricating, For Transurethral Surgical Instrument, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FHX
Device name
Jelly, Lubricating, For Transurethral Surgical Instrument
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code FHX

By decision year
6 clearances under product code FHX with a decision year between 1977 and 2008, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FHX by decision year
YearClearances
19771
19781
19911
19941
19951
20081

Applicants with the most clearances

Product code FHX
Applicants holding the most 510(k) clearances under product code FHX
ApplicantClearances
Farco Pharma GmbH1
Fibertech Instruments, Inc.1
General Medical Co.1
Johnson & Johnson Professionals, Inc.1
Pharmazeutische Fabrik Montavit GmbH1
Travenol Laboratories, S.A.1

Companies listing this code with FDA

Companies whose registered establishments list this code