3.7mm Diagnostic Sheath

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name: 3.7mm Diagnostic Sheath FDA UDI
Generic Name: Rigid optical hysteroscope FDA UDI
Device Name: The OMNI™Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. FDA UDI
Model / Reference: 60-201 FDA UDI
Description: The OMNI™Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. FDA UDI

Identifiers

Catalog Number: 60-201 FDA UDI
Primary DI / UDI-DI: 15420045510265 FDA UDI
510(k) Number: K182006 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rigid optical hysteroscope

3.7mm Diagnostic Sheath by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical hysteroscope.

TruClear — Covidien LP · Class II
BR Surgical, LLC — BR SURGICAL LLC · Class II
TRUCLEAR — Smith & Nephew, 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

K182006 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: Hologic, Inc.

Sources (1)

FDA UDI 3e49866e-9fa7-4314-988d-54c5037666b1 37 fields · synced Jun 1, 2026