Identity
- Trade Name
- Suction/irrigation tube 5.3 x 360 mm, button, unipolar, for HiQ+ handle EUDAMEDOlympus FDA UDI
- Generic Name
- Suction cannula, reusable FDA UDI
- Device Name
- Suction/Irrigation HiQ - tube monopolar EUDAMEDSuction/irrigation tube, 5 x 360 mm, button, unipolar, for HiQ+ handle FDA UDI
- Model / Reference
- WA51138A EUDAMEDFDA UDI
- Description
- Suction/irrigation tube, 5 x 360 mm, button, unipolar, for HiQ+ handle FDA UDI
Identifiers
- Catalog Number
- WA51138A FDA UDI
- Primary DI / UDI-DI
- 04042761024341 EUDAMEDFDA UDI
- Basic UDI-DI
- 40427611102852 EUDAMED
- Direct Marketing DI
- 04042761024341 EUDAMED
- 510(k) Number
- K923982 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L180502 ENDOSCOPIC ELECTROSURGERY MULTIFUNCTIONAL CANNULAS, REUSABLE EUDAMED
- GMDN Term
- Suction cannula, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Suction cannula, reusable
Olympus by Olympus Winter & Ibe GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K923982 also covers:
- Olmypus — 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
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
Sources (2)
- FDA UDI c386ada8-9245-4cce-8fe5-01164d1421d6 36 fields · synced Jul 8, 2026
- EUDAMED bc1f47fb-cb51-4a5b-a8f3-61d1180cddc5 61 fields · synced Jun 18, 2026