Laparoscope 162 103 253
Laparoscope 162 103 253 is a Class II device made by SOPRO-COMEG GmbH, cleared under FDA 510(k) K945266 on 23 Feb 1995 and listed in FDA GUDID since 20 Mar 2018 (UDI-DI 04059082032238), 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 | Number04059082032238 | Date20 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK945266 | Date23 Feb 1995 | StatusActive |
Official records
- AccessGUDID record 04059082032238
- FDA 510(k) database K945266
Across registries
- FDA 510(k) K945266 decided 23 Feb 1995 Active
- FDA GUDID UDI-DI 04059082032238 listed 20 Mar 2018 Listed
Timeline
- Cleared FDA 510(k) K945266
- Listed FDA GUDID 04059082032238
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Laparoscope
- Generic name
- Rigid optical laparoscope
- Model / reference
- 162 103 253
- Primary DI / UDI-DI
- 04059082032238
- 510(k) Number
- FDA product code
- GCJ
- GMDN term
- Rigid optical laparoscope
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Rigid optical laparoscope.
- Gimmi E.8292.00 by Gimmi GmbH
- Olympus WA4KL545 by Olympus Winter & Ibe GmbH
- AIM (Advanced Imaging Modality) 0502937030 0502-937-030 by Stryker Corp.
- CONMED HD1030 by Conmed Corporation
- Olympus WA4KL500 by Olympus Winter & Ibe GmbH
- CONMED UHD1030XL by Conmed Corporation
- Gimmi E.8292.45 IV by Gimmi GmbH
- 470066 by Intuitive Surgical, Inc.
- AIM (Advanced Imaging Modality) 0502537010 0502-537-010 by Stryker Corp.
- 470057 by Intuitive Surgical, Inc.