Insufflator OPTO-IFL1000
by Guangdong Optomedic Technologies, Inc. 2 variants
Insufflator OPTO-IFL1000 is a Class II device made by Guangdong Optomedic Technologies, Inc., cleared under FDA 510(k) K231342 on 20 Sep 2023 and listed in FDA GUDID since 26 Mar 2024 (UDI-DI 06973031299887), active as of 22 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 | Number06973031299887 | Date26 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231342 | Date20 Sep 2023 | StatusActive |
Official records
- AccessGUDID record 06973031299887
- FDA 510(k) database K231342
Across registries
- FDA 510(k) K231342 decided 20 Sep 2023 Active
- FDA GUDID UDI-DI 06973031299887 listed 26 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K231342
- Listed FDA GUDID 06973031299887
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Insufflator
- Generic name
- Laparoscopic insufflator
- Model / reference
- OPTO-IFL1000
- Primary DI / UDI-DI
- 06973031299887
- 510(k) Number
- FDA product code
- HIF
- GMDN term
- Laparoscopic insufflator
- Device class
- Class II
- Regulation number
- 884.1730
- GUDID distribution status
- In Commercial Distribution
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