Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Rigid optical ureteroscope FDA UDI
- Model / Reference
- WA2UR32A FDA UDI
Identifiers
- Catalog Number
- WA2UR32A FDA UDI
- Primary DI / UDI-DI
- 04042761086578 FDA UDI
- 510(k) Number
- K200369 FDA UDI
- FDA Product Code
- FGB FDA UDI
- GMDN Term
- Rigid optical ureteroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical ureteroscope
Olympus by Olympus Winter & Ibe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical ureteroscope.
- SlimLine — Gyrus Acmi, Inc. · Class II
- Bagley — Gyrus Acmi, Inc. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- SlimLine — Gyrus Acmi, Inc. · Class II
- Masimo SET — MASIMO CORPORATION · Class II
- SlimLine — Gyrus Acmi, Inc. · Class II
- IEC-Innoview GmbH — INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C. · Class II
Cleared under the same submission
K200369 also covers:
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe 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
- Olympus Winter & Ibe GmbH
Sources (1)
- FDA UDI 6f1d515c-5d96-47b7-878c-e315c39aa84a 35 fields · synced May 30, 2026