Product Code: FHX FDA class 2 21 CFR 876.1500

Jelly, Lubricating, For Transurethral Surgical Instrument

Gastroenterology, Urology

The Lubricating Jelly for Transurethral Surgical Instruments is a sterile gel applied to transurethral instruments prior to insertion to reduce friction and patient discomfort during urological procedures. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party 510(k) review. The product code is FHX, regulated under 21 CFR 876.1500, within the Gastroenterology, Urology specialty.

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510(k)s

FEI Numbers

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Basic Information

Product Code: FHX
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K081990	LUBRICANO STERILE GEL	Dec 05, 2008	Substantially Equivalent	Farco Pharma GmbH
K951713	BUTTON LUBRICATOR	Apr 25, 1995	Substantially Equivalent	Fibertech Instruments, Inc.
K935548	CATHEJELL S STERILE LUBRICATING JELLY	Mar 30, 1994	Substantially Equivalent	Pharmazeutische Fabrik Montavit GmbH
K912132	OPERAND LUBRICATING JELLY	Aug 07, 1991	Substantially Equivalent	General Medical Co.
K780386	K-Y LUBRICATING JELLY	Apr 13, 1978	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K771364	LUBE JEL	Aug 02, 1977	Substantially Equivalent	Travenol Laboratories, S.A.