Identity
- Trade Name
- Olympus FDA UDI
- Generic Name
- Laparoscopic access cannula, reusable FDA UDI
- Device Name
- Trocar tube "High-Flow", 4 mm, 2 stopcocks, rotatable FDA UDI
- Model / Reference
- A70951A FDA UDI
- Description
- Trocar tube "High-Flow", 4 mm, 2 stopcocks, rotatable FDA UDI
Identifiers
- Catalog Number
- A70951A FDA UDI
- Primary DI / UDI-DI
- 04042761010573 FDA UDI
- 510(k) Number
- K951354 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Laparoscopic access cannula, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 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: Laparoscopic access cannula, reusable
Olympus by Olympus Winter & Ibe GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic access cannula, reusable.
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Single-Site — Intuitive Surgical, Inc. · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- ELMED — ELMED INCORPORATED · Class II
- Gimmi — Gimmi GmbH · Class II
- BLUEENDO — TROKAMED GmbH · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- AESCULAP — AESCULAP, INC. · Class II
Cleared under the same submission
K951354 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 c6d95346-ca11-40bd-b157-a80852c76d91 36 fields · synced May 30, 2026