GeniLook

FDA UDI

Class I (US FDA UDI)

by Genicon

Identity

Trade Name: GeniLook FDA UDI
Generic Name: Laparoscopic access cannula, single-use FDA UDI
Model / Reference: 200-008-150 FDA UDI

Identifiers

Primary DI / UDI-DI: 00877972003809 FDA UDI
510(k) Number: K982472 FDA UDI
FDA Product Code: GEA FDA UDI
GMDN Term: Laparoscopic access cannula, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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: Laparoscopic access cannula, single-use

GeniLook by Genicon — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic access cannula, single-use.

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SECQURE Ultimate — SECQURE SURGICAL, CORP. · Class II
Secondary trocar with Gas Port + Additional Cannula without Gas Port — PURPLE SURGICAL INTERNATIONAL LIMITED · Class II
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BluView — Unimax Medical Systems Inc. · Class II
Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II

Cleared under the same submission

K982472 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 I	Pending data

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Manufacturer

Manufacturer: Genicon

Sources (1)

FDA UDI 5583b329-d363-4510-9596-1daad4ed0470 33 fields · synced May 30, 2026