Insufflator (OPTO-IFL1000)
Device Facts
| Record ID | K252318 |
|---|---|
| Device Name | Insufflator (OPTO-IFL1000) |
| Applicant | Guangdong Optomedic Technologies, Inc. |
| Product Code | HIF · Obstetrics/Gynecology |
| Decision Date | Apr 16, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1730 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
