AURORA® Surgiscope®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: AURORA® Surgiscope® FDA UDI
Generic Name: Endoscopic video image processing unit FDA UDI
Device Name: AURORA® Surgiscope® System FDA UDI
Model / Reference: ICB/ASX15 FDA UDI
Description: AURORA® Surgiscope® System FDA UDI

Identifiers

Catalog Number: ICB/ASX15 FDA UDI
Primary DI / UDI-DI: 00850002332261 FDA UDI
510(k) Number: K232618 FDA UDI
K250752 FDA UDI
FDA Product Code: GWG FDA UDI
GZT FDA UDI
GMDN Term: Endoscopic video image processing unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1480 FDA UDI
882.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Endoscopic video image processing unit

AURORA® Surgiscope® by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Endoscopic video image processing unit.

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3NT Video Console — 3nt Medical , Ltd. · Class II
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IMAGE1 X-LINK — Karl Storz GmbH & Co. KG · Class II

Cleared under the same submission

K232618 also covers:

K250752 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: Integra Lifesciences Corp.

Sources (1)

FDA UDI a2f9c98a-feb9-4b3d-9787-80ff8ddcb569 36 fields · synced Jun 8, 2026