Identity
- Trade Name
- Endosee FDA UDI
- Generic Name
- Flexible fibreoptic hysteroscope FDA UDI
- Device Name
- Endosee® Hysteroscope with Charging Station/Power Supply/USB Cable FDA UDI
- Model / Reference
- DMES8000 FDA UDI
- Description
- Endosee® Hysteroscope with Charging Station/Power Supply/USB Cable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937013177 FDA UDI
- 510(k) Number
- K123151 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Flexible fibreoptic 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible fibreoptic hysteroscope
Endosee by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic hysteroscope.
- OES HYSTEROFIBERSCOPE — Olympus Medical Systems Corporation · Class II
- LUMINELLE DTx Hysteroscopy System — Uvision360, Inc. · Class II
- Luminelle DTx Control Hub — Uvision360, Inc. · Class II
- Uvision Hysteroscope Cable — Uvision360, Inc. · Class II
- OES HYSTEROFIBERSCOPE — Olympus Medical Systems Corporation · Class II
- Endosee System — CooperSurgical, Inc. · Class II
- Endosee — CooperSurgical, Inc. · Class II
- Endosee System Convenience Kit — CooperSurgical, Inc.
Cleared under the same submission
K123151 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI f647eaeb-a1d9-47e7-a1a9-70c59a85fa1d 34 fields · synced Jun 9, 2026