Identity
- Trade Name
- 30 Degree 6mm operative 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
- 60-203-30 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
- 60-203-30 FDA UDI
- Primary DI / UDI-DI
- 15420045513648 FDA UDI
- 510(k) Number
- K191281 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical hysteroscope
30 Degree 6mm operative 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
K191281 also covers:
- 30 Degree 3.7mm Diagnostic Sheath — Hologic, Inc.
- 30 Degree 5.5mm operative sheath — Hologic, Inc.
- 30 Degree Omni Hysteroscope — Hologic, Inc.
- 30 Degree Omni Hysteroscope — Hologic, Inc.
- 30 Degree Omni Hysteroscope Outflow Channel — Hologic, Inc.
- 30 Degree Omni Hysteroscope XL Outflow Channel — Hologic, Inc.
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 794ee73d-ef1e-4556-a577-fe36c5f3d38c 37 fields · synced May 30, 2026