Identity
- Trade Name
- Valve tube, for HiQ+ handle, suction channel 8 mm, 1 pcs. EUDAMEDOlympus FDA UDI
- Generic Name
- Endoscope suction valve, reusable FDA UDI
- Device Name
- Suction/Irrigation HiQ - valve tube EUDAMEDValve tube, for HiQ+ handle, suction channel 8 mm, 1 pcs. FDA UDI
- Model / Reference
- WA51181L EUDAMEDFDA UDI
- Description
- Valve tube, for HiQ+ handle, suction channel 8 mm, 1 pcs. FDA UDI
Identifiers
- Catalog Number
- WA51181L FDA UDI
- Primary DI / UDI-DI
- 04042761052641 EUDAMEDFDA UDI
- Basic UDI-DI
- 40427611102954 EUDAMED
- Direct Marketing DI
- 04042761052641 EUDAMED
- 510(k) Number
- K923982 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L1299 LAPAROSCOPIC AND THORACOSCOPIC INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Endoscope suction valve, reusable FDA UDI
Classification
- Device Class
- Class IIa 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: Endoscope suction valve, reusable
Olympus by Olympus Winter & Ibe GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope suction valve, reusable.
- EM — Allied Medical LLC · Class I
- Suction valve — Olympus Medical Systems Corporation · Class II
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik · Class II
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik · Class II
- SUCTION VALVE — Olympus Medical Systems Corporation · Class II
- SUCTION VALVE — Olympus Medical Systems Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class I
- PENTAX — HOYA CORPORATION · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
Sources (2)
- FDA UDI ec30c478-5009-47fa-842b-424d18707c5f 36 fields · synced Jul 15, 2026
- EUDAMED 2e05294b-001d-4f99-9d37-1faa6557dd01 61 fields · synced Jul 15, 2026