IEC-Innoview GmbH

FDA UDI

Class II (US FDA UDI)

by Innovative Endoscopy Components, L.l.c.

Identity

Trade Name: IEC-Innoview GmbH FDA UDI
Generic Name: Rigid optical ureteroscope FDA UDI
Device Name: Semi-rigid Uretero Renoscope 6.0/7.5 Fr. 5 deg., direct/straight view, L=430 mm, autoclavable FDA UDI
Model / Reference: 30-0646-00 FDA UDI
Description: Semi-rigid Uretero Renoscope 6.0/7.5 Fr. 5 deg., direct/straight view, L=430 mm, autoclavable FDA UDI

Identifiers

Catalog Number: 30-0646-00 FDA UDI
Primary DI / UDI-DI: B192300646000 FDA UDI
510(k) Number: K062707 FDA UDI
FDA Product Code: FGB FDA UDI
GMDN Term: Rigid optical ureteroscope 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

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 6.0 French FDA UDI
Angle — 5 degree FDA UDI
Catheter Gauge — 7.5 French FDA UDI
Length — 430 Millimeter FDA UDI

Category: Rigid optical ureteroscope

IEC-Innoview GmbH by Innovative Endoscopy Components, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical ureteroscope.

Olympus — Olympus Winter & Ibe GmbH · Class II
SlimLine — Gyrus Acmi, Inc. · Class II
Bagley — Gyrus Acmi, Inc. · Class II
Gyrus ACMI — Gyrus Acmi, Inc. · Class II
Gyrus ACMI — Gyrus Acmi, Inc. · Class II
Olympus — Olympus Winter & Ibe GmbH · Class II
SlimLine — Gyrus Acmi, Inc. · Class II
Masimo SET — MASIMO CORPORATION · Class II

Cleared under the same submission

K062707 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: Innovative Endoscopy Components, L.l.c.

Sources (1)

FDA UDI 94e62b96-c298-4a32-ba96-70d04f54a54e 36 fields · synced May 30, 2026