Olympus A70950A
Olympus A70950A is a Class II device made by Olympus Winter & Ibe GmbH, cleared under FDA 510(k) K951354 on 14 Jun 1995 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761010566), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04042761010566 | Date21 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK951354 | Date14 Jun 1995 | StatusActive |
Official records
- AccessGUDID record 04042761010566
- FDA 510(k) database K951354
Across registries
- FDA 510(k) K951354 decided 14 Jun 1995 Active
- FDA GUDID UDI-DI 04042761010566 listed 21 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K951354
- Listed FDA GUDID 04042761010566
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Olympus
- Generic name
- Laparoscopic access cannula, reusable
- Model / Ref / Catalog
- A70950A
- Description
- Trocar tube "HighFlow", 4 mm, 1 stopcock, rotatable
- Primary DI / UDI-DI
- 04042761010566
- FDA product code
- HRX
- GMDN term
- Laparoscopic access cannula, reusable
- Device class
- Class II
- Regulation number
- 888.1100
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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