Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- Jaws "HiQ+", bipolar, 5 x 430 mm, grasping forceps, tweezers, long FDA UDI
- Model / Reference
- WA64211C FDA UDI
- Description
- Jaws "HiQ+", bipolar, 5 x 430 mm, grasping forceps, tweezers, long FDA UDI
Identifiers
- Catalog Number
- WA64211C FDA UDI
- Primary DI / UDI-DI
- 04042761063500 FDA UDI
- 510(k) Number
- K984417 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
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: Rigid endoscopic tissue manipulation forceps, reusable
Olympus by Olympus Winter & Ibe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rigid endoscopic tissue manipulation forceps, reusable.
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- Slide n Lock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
Cleared under the same submission
K984417 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
- 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 |
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Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
Sources (1)
- FDA UDI f1df6bc3-aa70-4e0e-96b1-fa10e437e97f 36 fields · synced May 30, 2026