GeniFlow

FDA UDI

Class II (US FDA UDI)

by Genicon

Identity

Trade Name: GeniFlow FDA UDI
Generic Name: Surgical irrigation/aspiration tubing set FDA UDI
Model / Reference: 700-000-010 FDA UDI

Identifiers

Primary DI / UDI-DI: 00877972004752 FDA UDI
510(k) Number: K041967 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Surgical irrigation/aspiration tubing set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical irrigation/aspiration tubing set

GeniFlow by Genicon — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation/aspiration tubing set.

LAMIS Tubing — Mentor Texas LP · Class I
Aspiration Tubing — BLACK & BLACK SURGICAL, INC. · Class II
MB ULTRA-LIMP TUBING — The Wells Johnson Company · Class II
INFILTRATION TUBING — BLACK & BLACK SURGICAL, INC. · Class II
Autofuse Tubing — Mentor Texas LP · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class II
ENDOFLOW II - PROBES - 4 holes diam.5 inch — Promepla · Class I
Hysteroscopy set 2 spikes — Promepla · Class II

Cleared under the same submission

K041967 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Genicon

Sources (1)

FDA UDI 906177b4-64bd-4c3d-b9ac-f1e8a0285ce2 33 fields · synced Jun 6, 2026