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 laparoscope FDA UDI
Device Name: 5 mm, 30 deg Laparoscope, L=300 mm, autoclavable, Large View FDA UDI
Model / Reference: 30-0495-00 FDA UDI
Description: 5 mm, 30 deg Laparoscope, L=300 mm, autoclavable, Large View FDA UDI

Identifiers

Catalog Number: 30-0495-00 FDA UDI
Primary DI / UDI-DI: B192300495000 FDA UDI
510(k) Number: K982276 FDA UDI
FDA Product Code: HET FDA UDI
GMDN Term: Rigid optical laparoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1720 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: Angle — 30 degree FDA UDI
Length — 300 Millimeter FDA UDI
Outer Diameter — 5.0 Millimeter FDA UDI

Category: Rigid optical laparoscope

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 laparoscope.

Laparoscope — SOPRO-COMEG GmbH · Class II
ELMED — ELMED INCORPORATED · Class II
Laparoscope — SOPRO-COMEG GmbH · Class II
HOPKINS — Karl Storz GmbH & Co. KG · Class II
MEDIVISION — MEDIVISION, INC. · Class II
Laparoscope — SOPRO-COMEG GmbH · Class II
CONMED — Conmed Corporation · Class II
ELMED — ELMED INCORPORATED · Class II

Cleared under the same submission

K982276 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 26042358-b495-490c-b1dc-b0d2cb1f81f9 36 fields · synced Jun 8, 2026