Identity
- Trade Name
- Hysteroscope FDA UDI
- Generic Name
- Rigid optical hysteroscope FDA UDI
- Model / Reference
- 163 282 990BC001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059082003795 FDA UDI
- 510(k) Number
- K945265 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical hysteroscope
Hysteroscope by SOPRO-COMEG GmbH — 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
- MyoSure XL Rod Lens Hysteroscope — Hologic, Inc. · 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
K945265 also covers:
- Accessory for gynecology — SOPRO-COMEG GmbH
- Accessory for gynecology — SOPRO-COMEG GmbH
- Cystoscopy instrument — SOPRO-COMEG GmbH
- Cystoscopy instrument — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SOPRO-COMEG GmbH
Sources (1)
- FDA UDI cd7a1015-ca08-488b-9344-de9b883971a7 33 fields · synced Jun 6, 2026