TruClear

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: TruClear FDA UDI
Generic Name: Rigid optical hysteroscope FDA UDI
Device Name: Operative Hysteroscope FDA UDI
Model / Reference: 7209208 FDA UDI
Description: Operative Hysteroscope FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521746664 FDA UDI
510(k) Number: K013870 FDA UDI
K031787 FDA UDI
FDA Product Code: HIH FDA UDI
GMDN Term: Rigid optical hysteroscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1690 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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 8 Millimeter FDA UDI

Category: Rigid optical hysteroscope

TruClear by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical hysteroscope.

BR Surgical, LLC — BR SURGICAL LLC · Class II
TRUCLEAR — Smith & Nephew, Inc. · Class II
MyoSure XL Rod Lens Hysteroscope — Hologic, Inc. · Class II
Hysteroscope — SOPRO-COMEG GmbH · Class II
HOPKINS — Karl Storz GmbH & Co. KG · Class II
Gimmi — Gimmi GmbH · Class II
HOPKINS — Karl Storz GmbH & Co. KG · Class II
AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II

Cleared under the same submission

K013870 also covers:

TruClear — Covidien LP

K031787 also covers:

TruClear — Covidien LP

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: Covidien LP

Sources (1)

FDA UDI db475b72-d07f-48ef-abd4-acba83279a3d 36 fields · synced May 30, 2026